FDA Adverse Event
Injury
Summary report: N
IOLMASTER 700
MDR report key: 7054172
·
Received November 22, 2017
Report
- Report Number
- 9615030-2017-00025
- Event Type
- Injury
- Date Received
- November 22, 2017
- Date of Event
- October 18, 2017
- Report Date
- October 27, 2017
- Manufacturer
- CARL ZEISS MEDITEC AG (JENA)
- Product Code
- HJO
- PMA / PMN Number
- K143275
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
MANUFACTURER NARRATIVE: THE DEVICE EVALUATION WAS COMPLETED BY THE MANUFACTURER ON MARCH 7, 2018. (B)(4).
Additional Manufacturer Narrative · 1
A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE DEVICE EVALUATION IS COMPLETED.
Description of Event or Problem · 1
THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THE FOLLOWING: THE OD REFRACTIVE OUTCOME AFTER CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANTATION DIFFERED BY 0.50 DIOPTER FROM THE TARGET REFRACTION. THE ALCON ACRYSOF IQ RESTOR IOL SN6AD1 WITH A LENS POWER OF 19.50 DIOPTERS WAS USED. THE HCP MADE A DECISION TO EXCHANGE THE IOL. THE IOLMASTER 700 WAS USED FOR THE ORIGINAL BIOMETRY MEASUREMENTS AND LENS POWER CALCULATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 833240 | IOLMASTER 700 | BIOMICROSCOPE, SLIT-LAMP, AC-POWERED | HJO | CARL ZEISS MEDITEC AG (JENA) | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Other |