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

Model Number N/A

Device Problems Incorrect Measurement (1383); Device Handling Problem (3265)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Review of the patient's measurement data showed that the patient's retina was not correctly identified by the iolmaster 700.The retina signal was superimposed by an oct scan artifact resulting from fingerprints on the front lens of the iolmaster.The device algorithms identified the artifact as the retina structure.This caused pre op measuring error for axial length.The user manual describes in detail how to evaluate measurement quality and contains warnings about relevant parameters.Proper cleaning of optical surfaces is also described in the user manual.

Event Description

A health care professional (hcp) reported that there had been an incorrect hyperopic surgical result after using the iolmaster 700 for the biometry measurements and lens power calculations.The hcp reported that a lens exchange will be 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: william gustafson ; 5160 hacienda drive; dublin, CA 94568 ; 9255574689
• MDR Report Key: 7940713
• MDR Text Key: 123051646
• Report Number: 9615030-2018-00007
• Device Sequence Number: 1
• Product Code: HJO
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K143275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• 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: 08/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2017
• 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