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

Model Number	700
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	04/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The most possible root cause was incorrect a-constants for the alcon toric vivity lens that the customer downloaded from the iolcon website.Alcon information on the iolcon site has been incorrect.There is no information that reasonably suggests that there was a malfunction of the iolmaster 700 that could have contributed to the unexpected surgical outcome and lens re-implantation.
Event or Problem Description
Customer reported post op surprise for their patient that had the alcon vivity lens.Therefore, a re-op lasik was performed.
Additional Manufacturer Narrative
Description of changes: g6: updated to "follow-up # 1 and 30-day".H2: selected "correction." h11: updated narrative.Update/correction to the narrative: it was noted in the original submission that the most possible root cause was an incorrect a-constants for the alcon toric vivity lens that the customer downloaded from the iolcon website.Alcon information on the iolcon site was noted to be incorrect.This was later found to not be the case, and the information regarding the vivity lens was actually correct on the website.However, this remains to be true that there is no information that reasonably suggests that there was a malfunction of the iolmaster 700 that could have contributed to the unexpected surgical outcome and lens re-implantation.

• Brand Name: IOLMASTER 700
• Common Device Name: 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: 22144014
• Report Number: 9615030-2025-00012
• Device Sequence Number: 12815947
• Product Code: HJO
• UDI-Device Identifier: 04049471092080
• UDI-Public: (01)04049471092080(11)190801
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K173771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2025

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
• Operator of Device: Health Professional
• Device Model Number: 700
• Device Catalogue Number: 000000-1932-169
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown