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

Model Number 500

Device Problem Insufficient Information (3190)

Patient Problem Visual Impairment (2138)

Event Type  Injury  

Event Description

A health care professional (hcp) reported that there had been an incorrect surgical result after using the iolmaster 500 for the biometry measurements and lens power calculations.The hcp reported that a lens exchange will be performed to correct the patient's vision.

Manufacturer Narrative

"date of this report" was omitted inadvertently from follow up report 1.Description of changes: field b4: added "date of this report" field h10: added manufacturer narrative, description of changes and corrected data.

Manufacturer Narrative

Three good faith efforts were made to obtain additional complaint information from the customer and to inspect the device.Customer is unresponsive.Description of changes: field d9: updated to "no".Field g1: updated contact office information.Field g6: updated to "30-day", "follow-up, # 1" field h2: selected "correction" "additional information" field h3: updated to "no", "other" field h6: added "investigation findings" code 3221, "investigation conclusions" code 4315.

• Brand Name: IOLMASTER 500
• 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: 9235612
• MDR Text Key: 164454570
• Report Number: 9615030-2019-00012
• Device Sequence Number: 1
• Product Code: HJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 500
• Device Catalogue Number: 000000-1692-983
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/29/2014
• 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