FDA Adverse Event
Injury
Summary report: N
LENSTAR LS 900
MDR report key: 2142492
·
Received June 21, 2011
Report
- Report Number
- 1000176188-2011-00001
- Event Type
- Injury
- Date Received
- June 21, 2011
- Date of Event
- March 15, 2011
- Report Date
- May 24, 2011
- Manufacturer
- HAAG-STREIT AG
- Product Code
- HJO
- PMA / PMN Number
- K082891
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ONLY THE DATABASE WILL BE RETURNED FOR MANUFACTURERS EVALUATION. THE DATABASE HAS NOT ARRIVED YET. DUE TO THE NATURE AND TYPE OF EXAMINATION, THE MEDICAL PROFESSIONAL PERFORMING THE EXAMINATION IS ADVISED TO VERIFY THE MEASUREMENT READING FOR PLAUSIBILITY AS NOTED IN THE DEVICE INSTRUCTION FOR USE. THE DISTRIBUTORS HAVE BEEN PROVIDED WITH A SOFTWARE UPDATE. THE ERROR RESPONSIBLE FOR THE EVENT HAS BEEN RECTIFIED.
Description of Event or Problem · 1
THE OPTICAL BIOMETER EXAMINATION RESULTS PRINTED WERE NOT CORRECT. THE PHYSICIAN SELECTED A LENS THAT WAS NOT BEST SUITABLE FOR THE PATIENTS CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LENSTAR LS 900 | LENSTAR | HJO | HAAG-STREIT AG | LS 900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |