MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1996-10-11 for PROSHIELD manufactured by Alcon Laboratories, Inc..
[28073]
Product did not dissolve and had to be removed from pt's eye. A corneal abrasion was observed and treated with antibiotic ointment and resolved in 5 days. The product was used after an uncomplicated cataract procedure and was soaked in tobradex prior to application. He reports the potential for injury exists if this incident were to recur.
Patient Sequence No: 1, Text Type: D, B5
[7766089]
The returned unopened products were subjected to in-vitro dissolution testing. Dissolution times were longer than previously seen for this product age. The longer dissolution time is believed to be related to mfg process changes early in 1996. As a result of these complaints we have changed back to the previous process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-1996-00007 |
| MDR Report Key | 42782 |
| Report Source | 05,06 |
| Date Received | 1996-10-11 |
| Date of Report | 1996-08-16 |
| Date of Event | 1996-08-15 |
| Date Mfgr Received | 1996-09-11 |
| Device Manufacturer Date | 1996-01-01 |
| Date Added to Maude | 1996-10-18 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROSHIELD |
| Generic Name | CORNEAL SHIELD |
| Product Code | MOE |
| Date Received | 1996-10-11 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | 6201620 |
| ID Number | K902558 |
| Device Expiration Date | 1998-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 43762 |
| Manufacturer | ALCON LABORATORIES, INC. |
| Manufacturer Address | 6201 SOUTH FREEWAY FORT WORTH TX 761342099 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-10-11 |