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

Catalog Number 000000-1692-983

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 07/13/2015

Event Type  Injury  

Event Description

The health care professional reported the following: the post refractive outcome for an eye cataract surgery with intraocular lens (iol) implantation was -8 diopters.The healthcare professional made a decision to exchange the iol.The iolmaster was used for the original biometry measurements and iol calculations as well as for the second measurement and calculation.

Manufacturer Narrative

A zeiss field service engineer (fse) inspected the device on site, and confirmed that the iolm 500 is working within specification.The manufacturer evaluated the patient related measurement and calculation printouts as well as the device log files.Based on the information obtained, the manufacturer was able to reproduce the sequence of the patient measurements done by the operator of the iolm 500 concluding that the initial five (5) axial length measurements for the patient were from another patient.These initial five measurements were printed and saved.Later, further five (5) measurements were performed with the correct patient under the same patient session.The combined data of these (10) measurements was used for the calculation of the intra-ocular lens (iol) resulting in an incorrect iol power value.Both printouts for measurement and calculation contained a warning message regarding the axial length values obtained for the affected patient due to the variation of the axial length measurements.The second patient was measured later again and all measurement values for this patient were correct.How to use the iolmaster 500 for iol calculation and how to use the lens constants is described in the user manual.For instance on page 65 of user manual (00000-1692-983_ga_gb_260210) it is stated "as a rule, the axial length should be viewed together with the corneal k's and overall refraction, and checked for plausibility.It is likewise helpful to compare the right and left eyes.".

• 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: william gustafson ; 5160 hacienda drive; dublin, CA 94568 ; 9255574689
• MDR Report Key: 5317141
• MDR Text Key: 34070661
• Report Number: 9615030-2015-00010
• Device Sequence Number: 1
• Product Code: HJO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K122418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 000000-1692-983
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/03/2015
• Initial Date FDA Received: 12/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2012
• 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): Other
• Patient Age: 74 YR