FDA Adverse Event
Malfunction
Summary report: N
C-FLEX
MDR report key: 1791233
·
Received August 5, 2010
Report
- Report Number
- 9611165-2010-00019
- Event Type
- Malfunction
- Date Received
- August 5, 2010
- Date of Event
- October 20, 2009
- Report Date
- August 5, 2010
- Manufacturer
- RAYNER INTRAOCULAR LENSES LTD.
- Product Code
- HQL
- PMA / PMN Number
- P060011A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF THE PARENT LENS MFG PROCESS RECORDS CONFIRMED NORMAL MFR AND STERILIZATION. NO OTHER COMPLAINTS OF ANY TYPE HAVE BEEN RECEIVED FOR ANY OTHER LENS FROM THIS LOT. THE PHYSICIAN (THE INITIAL REPORTER) INDICATED THAT THE PT¿S LENS WAS ¿CLEAR¿ PRIOR TO RETINAL SURGERY. THE REASON WHY THIS REPORT IS REPORTED LATE AND NOT WITHIN THE 30 DAYS PERIOD, IS DETAILED IN THE COVER LETTER DATED (B)(6) 2010, WHICH ACCOMPANIED THIS REPORT. (B)(4).
Description of Event or Problem · 1
THE LENS DEVELOPED AN OPACITY AND VISION WAS IMPAIRED. LENS HAD TO BE EXCHANGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | C-FLEX | INTRAOCULAR LENS | HQL | RAYNER INTRAOCULAR LENSES LTD. | 570C | 036E6569505 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention |