MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-09-03 for OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER 0065028545 manufactured by Alcon Laboratories, Inc. - Aspex.
[24946864]
Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[24946865]
This complaint is in reference to the alcon/ciba vision product opti-free express contact lens care solution and supra cleans contact lens cleaner. The complaint involves a report that a consumer was wearing a certain brand of lenses during the week of (b)(6) /2015. She was then put into a different brand of lenses on (b)(6) 2015 and experienced itching. The consumer went to the first ecp (eye care provider) and was diagnosed with an ulcer. The consumer was using both products during the course of these events. At the ecp, she was prescribed moxifloxacin on (b)(6) 2015 for use for the duration of one week. The consumer chose not to use it because it was too expensive. She therefore went to a second ecp where she was prescribed ofloxacin for use every two hours for three days to be used until (b)(6) 2015. She was also given fluorometholone for use four times a day for one week. On (b)(6) 2015, the consumer was released with no further follow-up needed and able to resume lens wear. On (b)(6) 2015 at 1am the consumer went to the er and was diagnosed with infiltrates and no treatment was provided. It was recommended that she see and specialist. At 9am on (b)(6) 2015, the consumer went to a third ecp and was diagnosed with infiltrates. She was prescribed moxifloxacin to be used five times a day along with prednisone. Additional information received on (b)(6) 2015 from the second ecp that the consumer went to, stated that she was diagnosed with an ulcer and was prescribed medication. The consumer stated that the medication was too expensive and therefore went to the third ecp for follow-up where she was prescribed cheaper medication to use. The second ecp stated that the patient came in on (b)(6) 2015 and was fitted in contact lenses on (b)(6) 2015. On (b)(6) 2015, the patient was dispensed a different brand of lenses until the correct brand arrived. On (b)(6) 2015, the patient wanted to try the first brand of lenses and ordered trials. The patient went in to the see the second ecp and stated that she had seen the first ecp and was given moxifloxacin, which the patient refused to fill because it was too expensive. The consumer asked the second ecp for a cheaper prescription. Additional information received on (b)(6) 2015 in the form of the completed ae form from the third ecp the patient saw after her er visit. The form stated that the date of event was (b)(6) 2015 and both eyes were involved. The lenses were worn for five to seven continuous days with a wear schedule of five to seven hours a day. The patient had a pre-existing condition of a corneal ulcer. The patient experienced severe pain/discomfort, moderate redness, watery discharge. No ulcer was present, but there were eight to ten infiltrates of unknown location and size. The clinical diagnosis was listed as corneal infiltrates. The patient was prescribed moxifloxacin and prednisolone four times a day in both eyes. The event has not yet resolved and a follow-up was scheduled for (b)(6) 2015. Lens wear has not yet resumed since the event is ongoing. Additional information received on (b)(6) 2015 in the form of the completed ae form from the second ecp. The form stated that the date of the event was (b)(6) 2015 and the right eye was involved. The patient wears lenses for seven continuous days. The number of days the lens was worn between onset of the symptoms and notification to practitioner was two days. The lenses were new at the time of the event. The patient has a medical history of asthma. The prescribed wear schedule is daily with a monthly replacement. The contributing factors to the event included water-related activities, with a patient report of h/o acanthamoeba at her pool. The event caused severe pain/discomfort, moderate redness, and watery discharge. There was an ulcer present with a peripheral location and 3mm in size. There were five infiltrates 3mm in size with a peripheral location. There was also moderate corneal staining with a severity of <50%. Permanent scarring is noted. The clinical diagnosis was a corneal ulcer in the right eye. The patient was prescribed moxifloxacin, one drop every hour for one week. It is noted that the event resolved but lens wear has not resumed because the patient is no longer a contact lens candidate. The event would recur upon resumption of lens wear. Additional information received on (b)(6) 2015 in the form of the completed ae form from the first attended ecp. The form stated that the date of the event was (b)(6) 2015 and that the patient reported that she was fitted into lens three days prior to the onset of the symptoms, and that she did not report a problem with the solution while in the office. Per the patient, the number of continuous days the lenses were worn was three days, and there were no contributing factors to the event. The patient experienced mild pain/discomfort in the left eye and moderate pain/discomfort in the right eye. There was mild redness in the left eye and moderate redness in the right eye, and there was also watery discharge. There was a peripheral corneal ulcer 3mm in size, with approximately six peripheral corneal infiltrates pinpoint in size. There was mild corneal staining at the ulcer site with <50% severity. The clinical diagnosis was a peripheral corneal ulcer in the right eye with subepithelial infiltrates in both eyes. Moxifloxacin was prescribed for use four times a day for seven days. It is unknown if the event resolved because a follow-up appointment was scheduled for (b)(6) 2015 but the patient cancelled it with no further scheduled appointments. It was also noted that the patient was examined and fitted for contact elsewhere, and had not returned for a follow-up as directed. Additional information received on (b)(6) 2015 from the third ecp stated that the consumer was last seen in the office on (b)(6) 2015 and no additional follow-up appointments were scheduled. The doctor's notes for the patient's (b)(6) 2015 visit were also received. The notes stated that the reason for the visit was for a one week cornea recheck for both eyes. The patient stated that her vision was good in both eyes. The patient was not using the prednisolone because she said it left a bad taste even after doing punctual occlusion. The current medications included moxifloxacin, one drop qid in both eyes and prednisolone acetate, one drop in both eyes. The anterior segment exam for both eyes revealed multiple small marginal opacities superiorly with the central cornea clear. The noted impression was infiltrate of the cornea. The plan was to use the moxifloxacin , one drop qid in both eyes one bottle one gtt five times a day in both eyes until sunday then decrease to qid in both eyes. It was to be discontinued as of (b)(6) 2015. The plan also included the prednisolone acetate, one drop qid in both eyes. It was to be discontinued a of (b)(6) 2015. A follow would only be scheduled if necessary.
Patient Sequence No: 1, Text Type: D, B5
[32166233]
The complaint product was not returned for evaluation at this time. The device history record and sterilization record for this lot have been reviewed and found to be in compliance. There was no nonconformity or deviations during the manufacturing process which related to the nature of the complaint. The root cause could not be determined. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[39091198]
The opened complaint product was returned for evaluation and was found to meet manufacturing specifications. An update to the manufacturing review was performed; the review did not indicate that this complaint was due to the manufacturing process. No complaint or manufacturing trend was identified. The root cause could not be determined. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2015-00529 |
| MDR Report Key | 5053885 |
| Report Source | CONSUMER |
| Date Received | 2015-09-03 |
| Date of Report | 2016-02-26 |
| Date Mfgr Received | 2016-02-08 |
| Device Manufacturer Date | 2014-12-04 |
| Date Added to Maude | 2015-09-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. EDDIE DARTON, MD, JD |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175686660 |
| Manufacturer G1 | ALCON LABORATORIES, INC. - ASPEX |
| Manufacturer Street | 6201 SOUTH FREEWAY |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 76134 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER |
| Generic Name | PRODUCTS, CONTACT LENS CARE, RIGID GAS PERMEABLE |
| Product Code | MRC |
| Date Received | 2015-09-03 |
| Returned To Mfg | 2016-01-08 |
| Model Number | NA |
| Catalog Number | 0065028545 |
| Lot Number | 233937F |
| Device Expiration Date | 2016-12-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON LABORATORIES, INC. - ASPEX |
| Manufacturer Address | 6201 SOUTH FREEWAY FORT WORTH TX 76134 US 76134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-09-03 |