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

Model Number 500

Device Problem Use of Device Problem (1670)

Patient Problem Visual Impairment (2138)

Event Date 07/07/2020

Event Type  Injury  

Manufacturer Narrative

Evaluation of provided patient data confirms that the axial length measurement values should have been checked.One the one hand this should have been done, as a short eye length of 20 mm is quite unusual (especially for a myopic patient as in the current case).On the other hand, the axial length readings are checked for plausibility by the iolmaster.This is described in the ifu.The note is located on the iol calculation printout, but the request for checking the axial length was not done by the user.

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 was performed to correct the patient's vision.

• 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, thuringia 07745 ; GM 07745
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thuringia 07745 ; GM 07745
• Manufacturer Contact: vernon brown ; 5160 hacienda drive; dublin, ca ; 5574616
• MDR Report Key: 10463140
• MDR Text Key: 204727000
• Report Number: 9615030-2020-00011
• 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 faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2011
• 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: 75 YR