MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 1996-10-04 for OPHTHALAS 532 LASER NA manufactured by Alcon Laboratories, Inc..
[28283]
A power surge during the procedure resulted in a stronger burn to the retina.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028159-1996-00163 |
| MDR Report Key | 40721 |
| Report Source | 05,06,07 |
| Date Received | 1996-09-04 |
| Date of Report | 1996-09-04 |
| Date of Event | 1996-08-06 |
| Date Mfgr Received | 1996-08-08 |
| Date Added to Maude | 1996-10-07 |
| 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 | RC |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPHTHALAS 532 LASER |
| Generic Name | LASER PHOTOCOAGULATOR |
| Product Code | HQB |
| Date Received | 1996-10-04 |
| Model Number | 532 LASER |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | K914334 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 41811 |
| Manufacturer | ALCON LABORATORIES, INC. |
| Manufacturer Address | 15800 ALTON PKWY IRVINE CA 92718 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-09-04 |