MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2013-04-11 for BIOTRUE MULTI-PURPOSE SOLUTION manufactured by Bausch + Lom.
[3272265]
Received correspondence from coopervision informing of a patient who was diagnosed with an infectious corneal ulcer while wearing biofinity toric lens and using biotrue multi-purpose solution. After four hours of wearing the lens, patient developed an uncomfortable feeling in right eye. Doctor determined the initial fit to be adequate. Within several days, the patient noticed a white mark on cornea, close to pupil, eye was red an irritated. Patient was treated for a corneal infiltrate/ulcer with a topical antibiotic and steroid combination drop. At follow up visit, the ulcer was 2. 5mm and had penetrated approximately 90% of the cornea. The ulcer was cultured and serratia marcescens was identified. After may visits and antibiotic therapy, the progression halted and the ulcer healed. The best visual acuity after the event was 20/50. Patient was evaluated by a corneal specialist who determined the best corrected visual acuity is 20/100. The only treatment to clear the patient's vision is a corneal transplant. Doctor relates event to the contact lens.
Patient Sequence No: 1, Text Type: D, B5
[10720072]
The device was not returned for evaluation and the lot number information is unknown. Doctor relates event to the contact lens.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1313525-2013-00003 |
| MDR Report Key | 3067880 |
| Report Source | 00,05 |
| Date Received | 2013-04-11 |
| Date of Report | 2013-04-01 |
| Date of Event | 2012-10-01 |
| Date Mfgr Received | 2013-04-01 |
| Date Added to Maude | 2013-04-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARLENE MARTRANO |
| Manufacturer Street | 1400 NORTH GOODMAN ST. |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853388995 |
| 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 |
| Product Code | LYL |
| Date Received | 2013-04-11 |
| 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 + LOM |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention; 3. Deathisabilit | 2013-04-11 |