MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-14 for BIO-COR 12 HOUR UNKNOWN manufactured by Bausch & Lomb.
[7637]
An ophthalmologist reported that 3 pts developed eye infections after implantation of an intraocular lens. All equipment and supplied used during the surgeries were examined. The sterilizer controls were correct. All solutions used during the procedues were cultured; results were negative. The reporter opened a sealed package of bio-cor and cultured the product; culture results were coagulase negative staphylococus. The pts received treatment and had no further problems. Event occurred on 1/12/94 and 2/2/94. Pts were an 81-yr-old male, and 86-yr-old male and a 75-yr-old female.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1000719 |
| MDR Report Key | 11436 |
| Date Received | 1994-02-14 |
| Date of Report | 1994-02-09 |
| Date of Event | 1994-01-12 |
| Date Added to Maude | 1994-02-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIO-COR 12 HOUR |
| Product Code | LYX |
| Date Received | 1994-02-14 |
| Catalog Number | UNKNOWN |
| Lot Number | DHR3088 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 11436 |
| Manufacturer | BAUSCH & LOMB |
| Manufacturer Address | ROCHESTER NY 14692 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-02-14 |