MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-08-07 for AOSEPT LENS CUP manufactured by Ciba Vision Corp..
[21393836]
Product malfunction involving one person. On 7/11/97, pt's clear lens cup exploded while disinfecting lens with enzyme. Is cup available for return: no; were lenses damaged: yes; lens type: sunsoft; parameters: 8. 9, 15. 0, -3. 25-2, 75x52; -2. 00-3. 50x135; date lenses dispensed: 8/23/96; date aosept dispensed: unk; was there personal injury; no/no medical treatment was required; was there any property damage: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1053053-1997-00001 |
| MDR Report Key | 111069 |
| Report Source | 07 |
| Date Received | 1997-08-07 |
| Date of Report | 1997-08-07 |
| Date of Event | 1997-07-08 |
| Date Mfgr Received | 1997-07-11 |
| Date Added to Maude | 1997-08-08 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AOSEPT LENS CUP |
| Generic Name | DISINFECTING UNIT |
| Product Code | HRD |
| Date Received | 1997-08-07 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | P820040 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 109065 |
| Manufacturer | CIBA VISION CORP. |
| Manufacturer Address | 11460 JOHNS CREEK PKWY. DULUTH GA 30097 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-08-07 |