FDA Adverse Event
Injury
Summary report: N
NA
MDR report key: 3634577
·
Received January 31, 2014
Report
- Report Number
- 3003563511-2014-00004
- Event Type
- Injury
- Date Received
- January 31, 2014
- Report Date
- January 9, 2014
- Manufacturer
- RAYNER INTRAOCULAR LENSES LTD.
- Product Code
- HQL
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
RAYNER INTRAOCULAR LENSES LIMITED RECEIVED NOTIFICATION FROM A UK HEALTHCARE FACILITY OF AN EVENT THAT OCCURRED FOLLOWING IMPLANTATION OF AN UNSPECIFIED RAYNER INTRAOCULAR LENS (IOL). THE PATIENT UNDERWENT IMPLANTATION OF A RAYNER TORIC IOL IN 2012 AND IN (B)(6) 2013 RETURNED TO SURGERY TO UNDERGO DESCEMET'S STRIPPING AUTOMATED ENDOTHELIAL KERATOPLASTY (DSAEK) FOR PSEUDOPHAKIC BULLOUS KERATOPHY. THE HEALTHCARE PROFESSIONAL REPORTS THAT 3 MONTHS POST DSAEK SURGERY THE PATIENT DEVELOPED OPACIFICATION OF THE IOL. FOR FURTHER INFORMATION PLEASE REFER TO RAYNER INTRAOCULAR LENSES LTD'S MDR 9611165-2014-00004.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 68340 | NA | HQL - INTRAOCULAR LENS | HQL | RAYNER INTRAOCULAR LENSES LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |