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

Model Number 700

Device Problem Output Problem (3005)

Patient Problem Visual Impairment (2138)

Event Date 03/03/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturer performed an analysis of the iol calculation printout provided by the customer.Iol zct 400 14.5 lens was recommended by the iolmaster 700.According to the customer, it should have been zct 600 14.5 lens.The manufacturer compared the iolmaster 700 calculation with the barrett and j&j online calculators.The barret online calculation recommended the zct 400 14.5, whereas the j&j online calculator recommended the zct 600 14.5.The barrett online agrees very strongly with the iolmaster 700 (as the barrett formula was also used here).This indicates that a user error is unlikely.The j&j online calculator has a large variation compared with the barrett formula and the iolmaster 700, which indicates that this issue maybe a result of the patient physiology.Statistically the barrett formula does show very good results over large patient sets which indicates this may be the unfortunate circumstance of the patient physiology causing a high variance in prediction capability.The iolmaster 700 only provides a recommendation.In such very steep iol cases it is always worthwhile to consult the manufacturer toric calculator for comparisons unless the surgeon is very experienced- but importantly the final decision always lies with the surgeon.Some deviations from the specification were found during device evaluation.However, none of these deviations have a influence on the accuracy of the measuring results and therefore could not have caused or contributed to the patient outcome.(b)(4).

Event Description

A health care professional (hcp) reported that there has been an incorrect surgical result after using the iolmaster 700 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 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: vernon brown ; 5160 hacienda drive; dublin, ca ; 5574689
• MDR Report Key: 9965280
• MDR Text Key: 187999566
• Report Number: 9615030-2020-00006
• Device Sequence Number: 1
• Product Code: HJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 700
• Device Catalogue Number: 000000-1932-169
• Device Lot Number: /
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR