MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2005-10-27 for ALLERGAN CUP (GORETEX) manufactured by Allergan, Inc..
[506864]
The manufacturer of a contact lens care cup for use with 3 percent hydrogen peroxide systems received a report from another country that three lens cups cracked during neutralization. No patient injury occurred. Each cup cracked on the bottom, slowly over a number of days, and solution eventually leaked through the cracks. The lens cups are not available for evaluation because they were discarded by the customer.
Patient Sequence No: 1, Text Type: D, B5
[7833585]
Cups not available for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020664-2005-00027 |
| MDR Report Key | 757887 |
| Report Source | 04 |
| Date Received | 2005-10-27 |
| Date of Report | 2005-10-17 |
| Date of Event | 2005-08-24 |
| Date Mfgr Received | 2005-08-24 |
| Date Added to Maude | 2006-09-08 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | AVERY FUNK |
| Manufacturer Street | 1700 E ST. ANDREW PLACE |
| Manufacturer City | SANTA ANA CA 92710 |
| Manufacturer Country | US |
| Manufacturer Postal | 92710 |
| Manufacturer Phone | 7142478601 |
| Manufacturer G1 | ALLERGAN |
| Manufacturer Street | 8301 MARS DRIVE |
| Manufacturer City | WACO TX 76712 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 76712 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALLERGAN CUP (GORETEX) |
| Generic Name | CONTACT LENS CARE PRODUCT |
| Product Code | HRD |
| Date Received | 2005-10-27 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 745787 |
| Manufacturer | ALLERGAN, INC. |
| Manufacturer Address | 8301 MARS DRIVE WACO TX 76712 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-10-27 |