MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2019-01-31 for AOSEPT PLUS/CLEAR CARE PLUS WITH HYDRAGLYDE CLEANING AND DISINFECTING SOLUTION 0003630004 manufactured by Alcon Laboratories, Inc..
[134566346]
(b)(4). The complaint sample has not returned for evaluation. 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
[134566347]
As initially reported by a consumer? S mother thru email on (b)(6) 2019, the consumer was diagnosed with acute painful bilateral corneal erosions, abrasions and conjunctival erythema dated (b)(6) 2019 with medical reports attached. This was believed to be the result of the consumer cleaning her biofinity coopervision contacts with novartis/alcon? S aosept plus with hydraglyde. The appellant reported that the consumer had experienced severe impaired vision on both eyes and could see? Rainbow/halos? Around light sources, also she complained of swollen, red eyes with acute pain which she described as stinging and burning with severe discomfort and sensitivity to light. On the report, the consumer had been using peroxide-based solution for a couple of years and said to adhere to the safety precaution of the product used and she just had recently switched to aosept plus with hydraglyde. She also added, that the consumer also uses the product for soaking contact lenses to be neutralized for eight hours without any issue and just before the incident the consumer had kept her lenses in a container with neutralizer for one week before using the contact lenses. She initially just experienced haziness in vision in the afternoon and excessive tearing during the night. However, at around 3:00 in the morning the consumer woke up to swollen, red eyes with excruciating pain and impaired visual acuity opting them to rush the client to the emergency department. Received additional information on (b)(6) 2019 stating the medications used by the consumer: sodium hyaluronate and xanthan gum eye gel, trehalose (3%) and hyaluronic acid (0. 15%) eye drops and dexpanthenol eye gel with unknown duration and frequency. Received additional information on (b)(6) 2019 stating the consumer? S eye status is getting much better. No more discomfort, no burning and stinging sensations reported, and no more excessive tearing. Also, the consumer? S father verbalized that his daughter was last checked on (b)(6) 2019 and stated that there were still corneal erosions near the center of cornea of both eyes. However, no mention on the percentage of the epithelial loss/erosion in the corneal surface, possibly still 10% of total surface. Received additional information on (b)(6) 2019 stating the medical treatment by the eye care professional (ecp) as follows, trehalose (3%) and hyaluronic acid (0. 15%) eye drops, to be given two to three times a day for ten days. The consumer was instructed to resume wearing contact lenses in ten days (new contact lenses without hydraglyde). Lastly, the consumer was instructed to come back for follow up one to three months for co and fao. Received additional information on (b)(6) 2019, the consumer? S father reported that the consumer does not have any more pain. The consumer? S visual acuity has been restored and now sees and feels completely normal. The consumer? S father added that the consumer? S right eye which has been more affected during the incident has now +0. 5 refractive power compared to -0. 5 before the incident. Additional information has been requested but not yet received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1610287-2019-00003 |
| MDR Report Key | 8291625 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2019-01-31 |
| Date of Report | 2019-04-26 |
| Date of Event | 2019-01-08 |
| Date Mfgr Received | 2019-04-09 |
| Device Manufacturer Date | 2017-11-28 |
| Date Added to Maude | 2019-01-31 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CINDY MILAM |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152231 |
| Manufacturer G1 | ALCON RESEARCH, LLC |
| Manufacturer Street | 6201 SOUTH FREEWAY |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 76134 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AOSEPT PLUS/CLEAR CARE PLUS WITH HYDRAGLYDE CLEANING AND DISINFECTING SOLUTION |
| Generic Name | ACCESSORIES, SOFT LENS PRODUCTS |
| Product Code | LPN |
| Date Received | 2019-01-31 |
| Model Number | NA |
| Catalog Number | 0003630004 |
| Lot Number | 290857F |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON LABORATORIES, INC. |
| Manufacturer Address | 6201 SOUTH FREEWAY FORT WORTH TX 76134 US 76134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-31 |