FDA Adverse Event
Injury
Summary report: N
ACRYSOF
MDR report key: 2318743
·
Received October 27, 2011
Report
- Report Number
- 1119421-2011-01310
- Event Type
- Injury
- Date Received
- October 27, 2011
- Date of Event
- January 1, 2011
- Report Date
- September 27, 2011
- Manufacturer
- ALCON RESEARCH, LTD. / HUNTINGTON
- Product Code
- HQL
- PMA / PMN Number
- P930014
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVAL SUMMARY: THE LENS WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY REVIEW INDICATED THE LENS MET RELEASE CRITERIA. THE ROOT CAUSE COULD NOT BE IDENTIFIED BY THE INVESTIGATION. THE CONSUMER DID NOT PROVIDE THE SURGEON'S CONTACT INFO; THEREFORE, NO F/U COULD BE CONDUCTED. (B)(4).
Description of Event or Problem · 1
A CONSUMER REPORTED POOR DISTANCE VISION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. HE STATED HE WENT TO A RETINAL SPECIALIST AND WAS TOLD EVERYTHING WAS FINE. HE REPORTED HE "DOES NOT BLAME THE IOL FOR HIS POOR VISION, BUT BELIEVES HIS ISSUE IS DUE TO THE MISCALCULATION OF LENS POWER BY HIS SURGEON." THE CONSUMER DID NOT PROVIDE THE SURGEON'S CONTACT INFO; THEREFORE, NO F/U COULD BE CONDUCTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACRYSOF | INTRAOCULAR LENS | HQL | ALCON RESEARCH, LTD. / HUNTINGTON | SN60WF | 11066247 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Other |