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

Catalog Number 000000-1932-169

Device Problem Incorrect Measurement (1383)

Patient Problem Visual Impairment (2138)

Event Date 10/25/2022

Event Type  Injury  

Event Description

The operator used the iolmaster 700 to measure the patient.The device automatically matched the data from the two left eye measurements to the left and right eyes respectively on (b)(6) 2022.Surgeon selected the + 18.5d iol according to the parameters and implanted the lens to patient on (b)(6) 2022.The patient reported that he could not see clearly after surgery and re-examine revealed lens error on nov.6, 2022.Surgeon had to surgically remove the wrong lens and re-implant the correct lens(+14.5d iol) on (b)(6) 2022.

• 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: 15974371
• MDR Text Key: 305412238
• Report Number: 9615030-2022-00010
• Device Sequence Number: 1
• Product Code: HJO
• UDI-Device Identifier: 04049471092080
• UDI-Public: (01)04049471092080(11)211201
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K170171
• 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: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 000000-1932-169
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2021
• 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: 71 YR
• Patient Race: Asian