FDA Adverse Event
Malfunction
Summary report: N
ENVISTA INTRAOCULAR LENS
MDR report key: 4635781
·
Received March 23, 2015
Report
- Report Number
- 1313525-2015-00451
- Event Type
- Malfunction
- Date Received
- March 23, 2015
- Report Date
- February 27, 2015
- Manufacturer
- BAUSCH & LOMB
- Product Code
- HQL
- PMA / PMN Number
- P910056
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- 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 THERE WAS NO SALINE IN THE VIAL AND SALT DEPOSITION WAS PRESENT ON THE OPTIC AND THE HAPTICS OF THE LENS. THIS ISSUE OCCURRED WITH 4 LENSES. NONE OF THE 4 LENSES WAS USED. THIS REPORT REFERENCES LENS 1 OF 4. REFERENCE MDR # 1313525-2015-00452 FOR LENS 2 OF 4, 131525-2015-00453 FOR LENS 3 OF 4, 1313525-2015-00454 FOR LENS 4 OF 4.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 194552 | ENVISTA INTRAOCULAR LENS | INTRAOCULAR LENS | HQL | BAUSCH & LOMB | MX60A | 3210317 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |