MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-09-15 for ALCON EYE SPEARS-CELLULOSE SPONGES- 10/PK 100010001 manufactured by Alcon Laboratories, Inc..
[1230617]
Product problem with cellulose eye spears. Spears are contained in custom cataract tray mfg by alcon laboratories, inc. Catalog number 11036-11. Spears catalog number is 100010001. Physician has noticed that eye spears-cellulose sponges-appear to shed strands of fiber. These are noticed prior to using in eye surgery cases and can potentially cause problems if fibers were to get into the eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5012753 |
| MDR Report Key | 1477355 |
| Date Received | 2009-09-15 |
| Date of Report | 2009-09-15 |
| Date Added to Maude | 2009-09-23 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALCON EYE SPEARS-CELLULOSE SPONGES- 10/PK |
| Generic Name | EYE SPEARS |
| Product Code | HOZ |
| Date Received | 2009-09-15 |
| Catalog Number | 100010001 |
| Lot Number | UNK |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON LABORATORIES, INC. |
| Manufacturer Address | 6201 SOUTH FREEWAY FT WORTH TX 76134 US 76134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-09-15 |