MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 1998-10-30 for NON-ANIMAL CATALASE B-12 manufactured by Allergan Pharmaceuticals (ireland) Ltd., Inc..
[17036362]
An optometrist reported that a male consumer initally experienced an ocular buring sensation upon instillation of lenses with use of ultracare neutralization tablets (nact) and disinfection solution. The following day when the pt rechallenged with product from the same lot he had the same experience and sought medical advice. The reporting eyecare specialist diagnosed first degree corneal erosion. As the pt suffers from aphakia and has no eyesight without corrective lenses he was unable to work for 3 days. Pt has recovered. The case was reported to the german moh, bfarm. Corrective treatment; treatment unk. Consumer was reported sick for 3 days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2011068-1998-00041 |
| MDR Report Key | 194675 |
| Report Source | 01,05 |
| Date Received | 1998-10-30 |
| Date of Report | 1998-07-03 |
| Date Mfgr Received | 1998-09-02 |
| Date Added to Maude | 1998-11-03 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NON-ANIMAL CATALASE B-12 |
| Generic Name | CONTACT LENS CARE PRODUCT |
| Product Code | MRC |
| Date Received | 1998-10-30 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | EC6763 |
| ID Number | NI |
| Device Expiration Date | 2000-04-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | I |
| Device Sequence No | 1 |
| Device Event Key | 189135 |
| Manufacturer | ALLERGAN PHARMACEUTICALS (IRELAND) LTD., INC. |
| Manufacturer Address | CASTLEBAR RD WESTPORT, COUNTY MAYO EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-10-30 |