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

Model Number	N/A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	03/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer evaluated the device and measurement & calculation printouts provided by the hcp.Based on the analysis, it can be confirmed that the event occured due to user error.The measured axial length value provided by the iolmaster 500 was not used for calculation.The axial length value was edited manually and caused the surgical surprise outcome.The ifu contains instructions and precautions to avoid measuring errors und informs about product-specific risks.The user manual describes in detail how to perform measurements on patients, subsequent calculation of intraocular lens power, and contains warnings about relevant parameters.
Event or Problem Description
A health care professional (hcp) reported that the axial length used for iol calculation was not the axial length that was measured by the iolmaster 500.The issue was not caught prior to surgery and a refractive surprise on the patient's right eye occurred.The doctor reported that he had implanted the wrong lens into the patient's eye.The patient is now near sided.The doctor reported that he is planning to explant the lens.

• Brand Name: IOL MASTER 500
• 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 ; 9252164697
• MDR Report Key: 14118811
• Report Number: 9615030-2022-00003
• Device Sequence Number: 4314289
• Product Code: HJO
• UDI-Device Identifier: 04049471092066
• UDI-Public: (01)04049471092066(11)210501
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K122418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2022

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: N/A
• Device Catalogue Number: 000000-1692-983
• Device Lot Number: N/A
• 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: 04/05/2022
• Initial Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Unknown