FDA Adverse Event
Injury
Summary report: N
IOLMASTER 700
MDR report key: 6184259
·
Received December 17, 2016
Report
- Report Number
- 9615030-2016-00011
- Event Type
- Injury
- Date Received
- December 17, 2016
- Report Date
- November 18, 2016
- Manufacturer
- CARL ZEISS MEDITEC AG (JENA)
- Product Code
- HJO
- PMA / PMN Number
- K143275
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THIS IS CASE TWO OF TWO REPORTED FROM SAME CUSTOMER SITE IN (B)(6). THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE POST REFRACTIVE OUTCOME AFTER A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION WAS DIFFERENT FROM THE TARGET REFRACTION. THE HEALTHCARE PROFESSIONAL MADE A DECISION TO EXCHANGE THE IOL. NO FURTHER INFORMATION REGARDING THE PATIENT AND INCIDENT COULD BE OBTAINED. THE HCP USED THE IOLMASTER 700 FOR THE BIOMETRY MEASUREMENTS AND IOL CALCULATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 834814 | IOLMASTER 700 | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED | HJO | CARL ZEISS MEDITEC AG (JENA) | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |