MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (JENA) IOLMASTER 500; BIOMICROSCOPE, SLIT-LAMP, AC-POWERED

Model Number 500

Device Problem Incorrect Measurement (1383)

Patient Problem Visual Impairment (2138)

Event Date 01/23/2023

Event Type  Injury  

Manufacturer Narrative

There is no indication that there was a malfunction of the zeiss device that could have contributed to the unexpected surgical outcome.Thus, the most possible root cause is a user error.A number of factors not related to the iolmaster may have influenced the measurements.Not all are controlled by the manufacturer.Measurement errors due to incorrect fixation or wearing of contact lenses could be conceivable.

Event Description

One patient was fitted with a wrong lens size.Customer confirmed that no errors have been observed from the iolmaster 500.A lens re-implantation was performed.

• Brand Name: IOLMASTER 500
• Type of Device: BIOMICROSCOPE, SLIT-LAMP, AC-POWERED
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thueringia 07745 ; GM 07745
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thueringia 07745 ; GM 07745
• Manufacturer Contact: manjaya hegde ; 5300 central parkway; dublin, CA 94568 ; 9252164697
• MDR Report Key: 17397691
• MDR Text Key: 319797620
• Report Number: 9615030-2023-00006
• Device Sequence Number: 1
• Product Code: HJO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K122418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 500
• Device Catalogue Number: 000000-1692-983
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention