FDA Adverse Event
Injury
Summary report: N
TRULIGN TORIC IOL
MDR report key: 3780652
·
Received April 18, 2014
Report
- Report Number
- 2031924-2014-00065
- Event Type
- Injury
- Date Received
- April 18, 2014
- Date of Event
- March 18, 2014
- Report Date
- March 24, 2014
- Manufacturer
- BAUSCH + LOMB
- Product Code
- MJP
- PMA / PMN Number
- P030002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 THE LENS DISLOCATED APPROX 1 MONTH POST IMPLANT. THE PT NOTICED A DECREASE IN VISION. THE LENS WAS REPOSITIONED AND A CAPSULAR TENSION RIGHT (CTR) WAS USED. THE SURGEON INDICATED THAT THE LIKELY CAUSE OF THE EVENT IS CAPSULE CONTRACTION SYNDROME. THE PT'S CURRENT PROGNOSIS IS DESCRIBED AS "GOOD". THIS REPORT PERTAINS TO THE PT'S LEFT EYE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 238647 | TRULIGN TORIC IOL | MJP/LENS, INTRAOCULAR, TORIC OPTICS | MJP | BAUSCH + LOMB | BL1UT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Other |