FDA Adverse Event
Injury
Summary report: N
CRYSTALSERT CRYSTALENS DELIVERY SYSTEM
MDR report key: 2926304
·
Received January 16, 2013
Report
- Report Number
- 2031924-2013-00010
- Event Type
- Injury
- Date Received
- January 16, 2013
- Date of Event
- November 27, 2012
- Report Date
- December 17, 2012
- Manufacturer
- BAUSCH + LOMB
- Product Code
- MSS
- PMA / PMN Number
- K082944
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING LENS IMPLANT, THE HAPTIC TORE THROUGH THE CAPSULAR BAG. THE LENS WAS REMOVED INTRAOPERATIVELY AND A VITRECTOMY WAS PERFORMED. THE PATIENT DEVELOPED CHOROIDAL HEMORRHAGING. THE SURGEON DECIDED TO LEAVE THE EYE APHAKIC AND THE PATIENT WAS REFERRED TO RETINA SPECIALIST FOR FURTHER EVALUATION. THE PATIENT'S CURRENT PROGNOSIS AND TREATMENT INCLUDE WEARING APHAKIC CONTACT LENS +12.00 PROCLEAR WITH OVER REFRACTION OF +2.00 TO 20/25. THIS EVENT REFERS TO THE PATIENT'S LEFT EYE. REFERENCE MDR # 2031924-2013-00009 FOR THE INTRAOCULAR LENS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 24808 | CRYSTALSERT CRYSTALENS DELIVERY SYSTEM | MSS/IOL INSERTER/INJECTOR | MSS | BAUSCH + LOMB | CI-28 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Other | CRYSTALENS ACCOMMODATING IOL |