MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-03-07 for CIBA VISION MEMORYLENS U940A manufactured by Ciba Vision Corp..
[265263]
Opacification of the implanted device was diagnosed (date unknown). Possible future explantation under eval. Several attempts have been made to obtain add'l info. No further info is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2648694-2003-00021 |
| MDR Report Key | 447206 |
| Report Source | 05 |
| Date Received | 2003-03-07 |
| Date of Report | 2003-02-07 |
| Date Mfgr Received | 2003-02-07 |
| Device Manufacturer Date | 1999-09-01 |
| Date Added to Maude | 2003-03-13 |
| 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 Contact | PAT STRAHL |
| Manufacturer Street | 11460 JOHNS CREEK PKWY |
| Manufacturer City | DULUTH GA 30097 |
| Manufacturer Country | US |
| Manufacturer Postal | 30097 |
| Manufacturer Phone | 6784153816 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CIBA VISION MEMORYLENS |
| Generic Name | INTRAOCULAR LENS |
| Product Code | HDL |
| Date Received | 2003-03-07 |
| Model Number | U940A |
| Catalog Number | U940A |
| Lot Number | * |
| ID Number | * |
| Device Expiration Date | 2000-10-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 436169 |
| Manufacturer | CIBA VISION CORP. |
| Manufacturer Address | EL JIBARO INDUST. PARK LOT #2, PO 1358 CIDRA PR 00739 US |
| Baseline Brand Name | CIBA VISION MEMORYLENS |
| Baseline Generic Name | INTRAOCULAR LENS |
| Baseline Model No | U940A |
| Baseline Catalog No | U940A |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-03-07 |