MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2013-09-12 for RENU FRESH MULTI-PURPOSE SOLUTION manufactured by Bausch & Lomb.
[3923477]
Patient wears a contact lens in left eye only. Upon insertion of lens, patient experienced pain, foreign body sensation, tearing and photophobia. She was treated for a corneal abrasion and completely recovered. The treating doctor reported that the injury "possibly" penetrated bowman's membrane as 80% of the cornea was involved and stromal haze was observed. There was no residual scar and no permanent decrease in visual acuity. Six weeks later, the patient tried the lens in the right eye and experienced burning. She saw a second doctor and was diagnosed and treated for a corneal abrasion. The second doctor indicated the injury was total surface and diagnosed chemical keratitis. Two days later, the right eye corneal abrasion was healing and a localized hazy area in the cornea on the left eye was reported. Following treatment, the patient recovered and at a follow up visit by the first doctor both corneas were totally recovered and clear. The second doctor also reported there were no scars and it did not appear that bowman's membrane was penetrated in either eye. The doctor felt the solution was the only factor present that could have caused the injury.
Patient Sequence No: 1, Text Type: D, B5
[11192449]
A trial size bottle approximately quarter full was returned. Testing of the solution revealed that it did not meet chemical specification requirements and it appeared that the original contents had been altered or replaced. A review of the lot batch records and chemical testing of a retain sample showed all requirements were met. It is concluded that the contents of the bottle were replaced after bausch and lomb distributed the product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1313525-2013-00009 |
| MDR Report Key | 3370032 |
| Report Source | 04,05 |
| Date Received | 2013-09-12 |
| Date of Report | 2013-06-25 |
| Date of Event | 2013-05-07 |
| Date Mfgr Received | 2013-08-27 |
| Device Manufacturer Date | 2013-01-01 |
| Date Added to Maude | 2013-09-27 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | TES PROUD |
| Manufacturer Street | 1400 NORTH GOODMAN ST. |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853388549 |
| Manufacturer G1 | BAUSCH & LOMB |
| Manufacturer Street | 8507 PELHAM RD. |
| 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 | RENU FRESH MULTI-PURPOSE SOLUTION |
| Product Code | LYL |
| Date Received | 2013-09-12 |
| Returned To Mfg | 2013-07-23 |
| Lot Number | GA3024 |
| Device Expiration Date | 2015-01-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-09-12 |