MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-11-16 for SOFT CELL 0525 manufactured by M-pact Corp.
[14870041]
Surgeon performed about 30 lasik procedures with sponges from one lot and noticed 12-14 eyes with (dlk) diffuse lamellar keratitis. Md had to lift flaps in two eyes and increased follow-up care for other eyes. Surgeon concluded that sponges from one lot are most likely the cause of increased dlk. Worst cases of dlk were on enhancements after using the sponges to push back the epithelium.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2083373-2001-00001 |
| MDR Report Key | 362368 |
| Report Source | 05 |
| Date Received | 2001-11-16 |
| Date of Report | 2001-11-08 |
| Date of Event | 2001-10-01 |
| Date Mfgr Received | 2001-10-18 |
| Device Manufacturer Date | 2001-08-01 |
| Date Added to Maude | 2001-12-03 |
| 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 | 0 |
| Manufacturer Street | 514 S. VERMONT AVE. |
| Manufacturer City | GLENDORA GA 91741 |
| Manufacturer Country | US |
| Manufacturer Postal | 91741 |
| Manufacturer Phone | 6269142891 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOFT CELL |
| Generic Name | PVA FOAM SPONGES |
| Product Code | HOZ |
| Date Received | 2001-11-16 |
| Model Number | 0525 |
| Catalog Number | 0525 |
| Lot Number | 1220C |
| ID Number | NA |
| Device Expiration Date | 2004-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 351513 |
| Manufacturer | M-PACT CORP |
| Manufacturer Address | 1040 OCL PARKWAY EUDORA KS 66025 US |
| Baseline Brand Name | SOFT CELL |
| Baseline Generic Name | PVA FOAM SPEARS |
| Baseline Model No | 0525 |
| Baseline Catalog No | 0525 |
| Baseline ID | NA |
| Baseline Device Family | PVA FOAM SURGICAL SPEARS |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K950241 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-11-16 |