MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 1997-04-30 for ALLERGAN CUP NI manufactured by Allergan Optical.
[17826115]
A female patient's lens case burst while using the system with b12. The cup burst and struck the patient's eyeglasses. The lenses broke and some fragments of glass got into the patient's eye. The patient was hospitalized with an eye injury and several glass fragments were removed from her eye. Subsequently, the patient was rehospitalized in a different city and additional glass fragments were removed. Co is awaiting further information from the reporting country regarding diagnosis, treatment, and determination as to whether or not the patient had used the correct cup.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2011068-1997-00039 |
| MDR Report Key | 87676 |
| Report Source | 01,05 |
| Date Received | 1997-04-30 |
| Date of Report | 1997-03-12 |
| Date of Event | 1997-03-08 |
| Date Mfgr Received | 1997-03-12 |
| Date Added to Maude | 1997-05-02 |
| 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 | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALLERGAN CUP |
| Generic Name | CONTACT LENS CARE PRODUCT |
| Product Code | HRD |
| Date Received | 1997-04-30 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | UNK |
| ID Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | I |
| Device Sequence No | 1 |
| Device Event Key | 86818 |
| Manufacturer | ALLERGAN OPTICAL |
| Manufacturer Address | 8301 MARS DR. WACO TX 76712 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1997-04-30 |