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

Model Number 700

Device Problem Use of Device Problem (1670)

Patient Problem Visual Impairment (2138)

Event Date 11/13/2023

Event Type  Injury  

Event Description

Customer reported that their patient had a correction performed (re-rotation of iol lenses / re-alignment of the lenses) after a surgical surprise.

Manufacturer Narrative

Based on provided information the issue is related to a misinterpretation of the surgeon printout provided by the iolmaster 700.The error was made while the doctor transitioned from using the barrett online iol calculator printout to the new surgeon printout of the iolmaster 700.The doctor ignored the axis information in the toric power section of the iolmaster 700 and used the residual astigmatism axis (res.Ast.) instead.This led to lens implantation with wrong axis.The device worked within and meets zeiss manufacturer specifications.

• 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, 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 ; 9255574100
• MDR Report Key: 18379446
• MDR Text Key: 331175908
• Report Number: 9615030-2023-00020
• Device Sequence Number: 1
• Product Code: HJO
• UDI-Device Identifier: 04049471092080
• UDI-Public: (01)04049471092080(11)230501
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K173771
• 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: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2023
• 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