FDA Adverse Event
Malfunction
Summary report: N
ENVISTA INTRAOCULAR LENS
MDR report key: 4092791
·
Received August 20, 2014
Report
- Report Number
- 1119279-2014-00198
- Event Type
- Malfunction
- Date Received
- August 20, 2014
- Report Date
- July 22, 2014
- Manufacturer
- BAUSCH & LOMB, INC.
- Product Code
- HQL
- PMA / PMN Number
- P910056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT UPON IOL LOADING, THE ANTERIOR HAPTIC WAS BENT INT HE MIDDLE INSTEAD OF THE HAPTIC-LENS JUNCTION. AS A RESULT, CAPSULAR RUPTURE OCCURRED UPON LENS INSERTION. THE SURGEON ATTRIBUTED THE EVENT TO POOR LOADING TECHNIQUE BY THE TECHNICIANS AND "RIGIDITY" OF THE LENS. NO INFORMATION HAS BEEN PROVIDED REGARDING THE TYPE OF INSERTER USED DURING THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NO ADDITIONAL INFORMATION HAS BEEN RECEIVED BY BAUSCH AND LOMB TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 500579 | ENVISTA INTRAOCULAR LENS | INTRAOCULAR LENS | HQL | BAUSCH & LOMB, INC. | MX60 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |