MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2018-06-14 for BIOTRUE MULTI-PURPOSE SOLUTION manufactured by Bausch & Lomb Incorporated.
[111136082]
Additional information has been requested but has not been received. A review of the lot batch records and testing of a retain sample is in progress. It should be noted that the normal product does not smell like "paint thinner?. Together with the consumer''s report that the lenses soaked in the product are warped, it is not clear whether the normal product caused the event or the product became adulterated with a foreign substance that changed the odor and caused the lenses to warp.
Patient Sequence No: 1, Text Type: N, H10
[111136083]
A retailer reported that one of their consumers experienced an adverse reaction after using the product. The consumer was contacted and reported that upon initial use, and for several uses after, she experienced minor burning associated with the product. According to the consumer, she continued to use the product and soaked her contact lenses for two days. Upon insertion of her lenses on (b)(6) 2018, she reported immediate severe burning. Because of the severity, the consumer indicated that she sought medical attention. The consumer stated that she was diagnosed with a chemical reaction in both eyes and prescribed an antibiotic (ofloxacin) to be used 3 times a day in the left eye and 2 times a day in the right eye for one week. In addition, she was to use artificial tears. As of (b)(6) 2018, the consumer indicated that she was no longer using the ofloxacin drops; however, she continues to use the artificial tears. The consumer reported that she had a follow-up visit on (b)(6) 2018 and had another follow-up with a different doctor (an ophthalmologist) on (b)(6) 2018 to assess how her eyes are healing. The consumer stated that her left eye does not seem to be getting any better. The consumer also stated that her lenses are still soaking in the product, the lenses are warped, and the product smells like "paint thinner. " the consumer indicated that she would return the product and provide the information for the two doctors. Although multiple attempts have been made to retrieve the product and doctor information, the consumer has not provided the materials/information.
Patient Sequence No: 1, Text Type: D, B5
[119995053]
The signed medical release and complaint product have been requested but have not yet been received. A review of the lot batch records and testing of a retain sample is in progress. Based on all information available, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[119995054]
On 18-june-2018, the consumer provided additional information related to the event. According to the consumer, her eyes are feeling better, she has returned to wearing contact lenses (different brand), and she is experiencing dry eye that she believes is a consequence of the reported incident. The consumer reported that, prior to this event, she had never experienced dry eye, and she continues to use artificial tears. The consumer provided contact information for the clinic she visited on (b)(6) 2018 and provided contact information for the ophthalmologist seen on (b)(6) 2018. The consumer reported that the clinic prescribed ofloxacin for her event and recommended that she use artificial tears, specifically systane ultra. The consumer stated that, when she visited the clinic for her follow-up appointment, she had been making use of the artificial tears every hour. In addition, the consumer stated that when she was seen at the clinic they noted dry spots on her eyes and stated that her left eye was worse than her right. While the consumer was not referred to an ophthalmologist by the clinic, the consumer stated that she was experiencing blurry vision and dry eyes and wanted to ensure that there was no permanent damage to her eyes. According to the consumer, the ophthalmologist did not see any permanent damage to her eyes and noted only dry eye, the ophthalmologist stated that the irritation present was consistent with a reaction to the contact lens solution, and the ophthalmologist prescribed a steroid (name unknown), which the ophthalmologist said she could use for inflammation if she were so inclined. The consumer indicated that she did not use the steroid drops, and instead, she increased the number of times she used the artificial tears per day. The consumer did not follow-up with the ophthalmologist. The consumer also reiterated that the contact lens solution inside her contact lens case smelled like paint thinner and caused her lenses to bow out and warp. The clinic visited by the consumer was contacted. The clinic representative indicated that the consumer was seen on (b)(6) 2018. No additional information was provided without a signed medical release. The ophthalmologist office was also contacted. The office representative indicated that the patient? S chart stated that on (b)(6) 2018 the patient was seen by the other clinic, was diagnosed with dry eye, prescribed ofloxacin, and instructed to use artificial tears. The record also indicated the patient reported that after a week of this treatment she was still not seeing improvement, and she continued to have itchy, aggravated (painful) eyes and fluctuating vision. For this reason, the patient booked the appointment with the ophthalmologist on (b)(6) 2018. The office representative reported that the ophthalmologist noted a few follicles with lid eversion in the right eye only, and everything else was normal: there was no staining or corneal involvement. According to the office representative, the patient was diagnosed with right eye orbital pain, the ophthalmologist reassured the patient that there was no permanent damage, and that the ophthalmologist had? No worries?. The patient was provided with a sample of ilevro ophthalmic suspension (anti-inflammatory) to use once per day and was also prescribed fml eye drops (anti-inflammatory) to be used twice per day. (to reiterate, consumer reported that she did not make use of either of these medications. ) according to the ophthalmologist? S office, the patient did not require any follow-up appointments. The office representative indicated that the ophthalmologist did not provide an opinion as to likely cause of the event, that the event was not considered life threatening, did not result in permanent impairment of a body function or permanent damage to a body structure, and did not necessitate medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2018-00118 |
| MDR Report Key | 7603667 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2018-06-14 |
| Date of Report | 2018-05-30 |
| Date of Event | 2018-05-18 |
| Date Mfgr Received | 2018-05-30 |
| Device Manufacturer Date | 2017-12-03 |
| Date Added to Maude | 2018-06-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JENNIFER GAMET |
| Manufacturer Street | 1400 NORTH GOODMAN STREET |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853386853 |
| Manufacturer G1 | BAUSCH + LOMB |
| Manufacturer Street | 8507 PELHAM ROAD |
| Manufacturer City | GREENVILLE SC 29615 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29615 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOTRUE MULTI-PURPOSE SOLUTION |
| Generic Name | ACCESSORIES, SOLUTION, CLEANERS FOR LENSES |
| Product Code | LYL |
| Date Received | 2018-06-14 |
| Returned To Mfg | 2018-09-04 |
| Lot Number | GL17109 |
| ID Number | NI |
| Device Expiration Date | 2019-11-01 |
| 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 | BAUSCH & LOMB INCORPORATED |
| Manufacturer Address | 1400 NORTH GOODMAN STREET ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-14 |