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 2018-12-06 for BIOTRUE ONEDAY(NESOFILCON A)CONTACT LENS manufactured by Bausch & Lomb Incorporated.
[129479021]
It was confirmed with the specialist office that it is unclear if the consumer will have permanent loss of vision. They attribute the cause of the ulcer to be contact lens wear. The consumer discarded the complaint lens, therefore it is not available for evaluation. A review of the manufacturing records concludes that the product was manufactured, packaged and released according to global and plant product specifications. Based on all available information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[129479022]
Medwatch report received from fda, mw5080879. Through the medwatch program it was reported that the consumer had a rapid onset of a severe infection in the right eye which led to permanent vision impairment. Follow up with the consumer revealed that after wearing the lenses for 12 hours, they had a very rapid onset of red eye, pain, tearing, discomfort and blurry vision in the right eye. The next day, (b)(6) 2018, the consumer visited the corneal specialist doctor where they were diagnosed with a central corneal ulcer. The exact dimensions are not available. Confirmed with the specialist that a corneal scraping was taken, however it was negative for bacterial growth. The patient was prescribed fortified vancomycin, fortified tobramycin and prednisolone once a day. The antibiotics were discontinued in (b)(6); they are still currently using prednisolone for inflammation. The patient followed up with the doctor every 4 days until (b)(6). In (b)(6) they followed up weekly until (b)(6), where they are now following up monthly. It was confirmed with the specialist office that at no time was the ulcer infectious. The patient has mostly recovered except they have a corneal scar which potentially can cause permanent loss of vision. They are currently being seen by an optometrist to be refit into contact lenses to accommodate the change in vision. The specialist attributes the event to contact lens wear. Every time the patient visits the specialist? S office their vision reads differently, it is difficult to tell if it will cause permanent vision loss.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2018-00226 |
| MDR Report Key | 8137542 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2018-12-06 |
| Date of Report | 2018-11-19 |
| Date of Event | 2018-06-11 |
| Device Manufacturer Date | 2017-11-09 |
| Date Added to Maude | 2018-12-06 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | UNIT 424/425, CORK ROAD INDUSTRIAL ESTATE |
| Manufacturer City | WATERFORD |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOTRUE ONEDAY(NESOFILCON A)CONTACT LENS |
| Generic Name | LENS, CONTACT, DISPOSABLE |
| Product Code | MVN |
| Date Received | 2018-12-06 |
| Lot Number | W77249902 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-12-06 |