MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-04-20 for CIBA VISION MEMORY LENS U9405 manufactured by Ciba Vision Corp.
[15443901]
A surgeon reported that a memory lens implanted in the right eye of an unspecified patient has opaque anterior surface noted since 2006. A yag was performed (date not provided) with no improvement. An iol exchange is being considered. Request has been made for additional information, however no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
[15653236]
The device history records & sterility records have been reviewed by manufacturing and found to be in compliance.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2648694-2007-00007 |
| MDR Report Key | 950024 |
| Report Source | 05 |
| Date Received | 2007-04-20 |
| Date of Report | 2007-03-20 |
| Date of Event | 2006-08-16 |
| Date Mfgr Received | 2007-03-20 |
| Device Manufacturer Date | 2000-08-01 |
| Date Added to Maude | 2007-11-21 |
| 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 | PAT STRAHL |
| Manufacturer Street | 11460 JOHNS CREEK PKWY. |
| Manufacturer City | DULUTH GA 30097 |
| Manufacturer Country | US |
| Manufacturer Postal | 30097 |
| Manufacturer Phone | * |
| Manufacturer G1 | CIBA VISION CORP |
| Manufacturer Street | EL JIBARO INDUSTRIAL PARK LOT # 2, PO BOX 1358 |
| Manufacturer City | CIDRA PR 00739 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00739 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CIBA VISION MEMORY LENS |
| Generic Name | INTRAOCULAR LENS |
| Product Code | HQZ |
| Date Received | 2007-04-20 |
| Model Number | U9405 |
| Catalog Number | U9405 |
| Lot Number | M547197 |
| ID Number | * |
| Device Expiration Date | 2001-09-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 921550 |
| Manufacturer | CIBA VISION CORP |
| Manufacturer Address | EL JIBARO INDUSTRIAL PARK CIDRA PR 00739 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-20 |