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

Catalog Number 266002-1141-139

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/23/2015

Event Type  malfunction  

Manufacturer Narrative

The manufacturer made several attempts to duplicate the reported problem as part of its complaint investigation, but was unable to duplicate the reported problem.The iolmaster 500 was found to be working within specification.As part of the continuing investigation, instrument log files were obtained from the site.Based on a review of the log files, the manufacturer subsequently determined that a specific workflow could result in the observed problem due to a software anomaly.A determination was made that this malfunction could potentially lead to the selection of a sub-optimal iol if not detected by the healthcare provider.

Event Description

It was reported that during a cataract consult the healthcare provider discovered that the iolmaster 500 had provided the wrong intraocular (iol) calculations for the patient when using the multi-formula function.The healthcare provider detected the anomaly because the iol lens power calculations for the technis za9003 lens were identical to those of the softport l161ao lens.As a result, the healthcare provider did not use the data to perform iol implantation.When the patient's measurement data was re-run at a later time using the technis za9003 lens, the lens achieved the expected lens power calculations.

Manufacturer Narrative

Field g5 pma/510(k) changed from k101182 to k122418 (correction).

Event Description

Na.

• 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: judy brimacombe ; 5160 hacienda drive; dublin, CA 94568 ; 9255574616
• MDR Report Key: 5149213
• MDR Text Key: 28649967
• Report Number: 9615030-2015-00007
• 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: user facility
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 266002-1141-139
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2015
• 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