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

Model Number N/A

Device Problem Incorrect Measurement (1383)

Patient Problem Visual Impairment (2138)

Event Date 01/06/2022

Event Type  Injury  

Manufacturer Narrative

The manufacturer evaluated the patient measurement printouts provided by the hcp.In addition, the device evaluation confirmed that the iolmaster 700 is working in specification.Based on the analysis, it can be concluded that the event occurred due to user error.There were no structures visible in the fixation check.There were multiple warning messages on the printouts regarding fixation check, unusual axial length and long eyes.If the iolmaster gives long al measurements (~34mm) it indicates a high myopia (ie.Long eye), and therefore cross-checking with the patient's refraction should be carried out.The recommended cross-check of measurements for plausibility and correct position of measurement marks was not performed by the user.In addition, the warning messages in the device gui were not observed by the user.According to the instruction for use the evaluation of measurement data should be performed by physicians considering the corresponding instructions for use.Users should not rely solely on measurements made using the iolmaster 700 in making decisions regarding the calculation and implantation of intraocular lenses or other therapeutic procedures but should rely on their own expertise and judgement.

Event Description

A health care professional(hcp) reported that there has been an incorrect surgical result after using the iol master 700 for the biometry measurements and lens power calculations.The hcp reported that a lens exchange was performed to correct the patient's vision.

• 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 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: 13419491
• MDR Text Key: 286675917
• Report Number: 9615030-2022-00001
• Device Sequence Number: 1
• Product Code: HJO
• UDI-Device Identifier: 04049471092080
• UDI-Public: (01)04049471092080(11)170901
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• 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: 000000-1932-169
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2020
• 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
• Patient Age: 79 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian