MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (JENA) IOLMASTER 700; BIOMICROSCOPE, SLIT-LAMP, AC-POWERED

Model Number 700

Device Problem Output Problem (3005)

Patient Problem Visual Impairment (2138)

Event Date 12/10/2019

Event Type  Injury  

Event Description

A health care professional (hcp) reported that there had been two incorrect surgical result after using the iolmaster 700 for the biometry measurements and lens power calculations.The hcp reported that in one case, a lens exchange was performed to correct the patient's vision.

Manufacturer Narrative

The manufacturer evaluated the provided patient data.Based on this evaluation the manufacturer concluded there was no malfunction, miscalculation, or wrong measurement coming from the iolmaster.Descriptions of changes: field g7: updated to "follow-up #: 1".Field h2: entered "additional information".Field h6: updated result code to "213", and updated conclusion code to "67".Field h10: added manufacturer narrative.Added descriptions of changes.

• Brand Name: IOLMASTER 700
• Type of Device: BIOMICROSCOPE, SLIT-LAMP, AC-POWERED
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, 07745 ; GM 07745
• MDR Report Key: 9566372
• MDR Text Key: 174721516
• Report Number: 9615030-2020-00001
• Device Sequence Number: 1
• Product Code: HJO
• Combination Product (y/n): N
• PMA/PMN Number: K143275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 700
• Device Catalogue Number: 000000-1932-169
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 01/08/2020
• Supplement Dates Manufacturer Received: 12/10/2019
• Supplement Dates FDA Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention