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

Model Number N/A

Device Problem Incorrect Measurement (1383)

Patient Problem Visual Impairment (2138)

Event Type  Injury  

Event Description

A health care professional (hcp) reported that the calculations being given by the iolmaster 500 are not correct.The hcp reported refractive surprises.At least one patient is having a lens exchange performed.

Manufacturer Narrative

The hcp declined a device evaluation.The hcp communicated that the issue is related to the technician's training, rather than the iolmaster 500 itself.

• Brand Name: IOL MASTER 500
• Type of Device: BIOMICROSCOPE, SLIT-LAMP, AC-POWERED
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thueringia 7745 ; GM 7745
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thueringia 7745 ; GM 7745
• Manufacturer Contact: manjaya hegde ; 5300 central parkway; dublin, CA 94568 ; 9252164697
• MDR Report Key: 17092980
• MDR Text Key: 316872802
• Report Number: 9615030-2023-00004
• Device Sequence Number: 1
• Product Code: HJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 000000-1692-983
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/29/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention