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

Model Number 700

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

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

Event Date 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

The customer was requested to put the iolmaster 700 out of service and to return the device for evaluation by the manufacturer.So far the device has not been returned for analysis.

Event Description

A health care professional (hcp) reported that the axial length (al) measurements of staff members taken on an iolmaster 700 are in average 0.06 mm greater than the al measurements taken on an iolmaster 500.The hcp confirmed that the test eye measurements of the iolmaster 500 were within specification.It cannot be confirmed that the iolmaster 700 did not malfunction.Any event of an unexpected refractive result on a patient, using the suspect iolmaster 700, are not known.

Manufacturer Narrative

Additional information was received on 7/17/2019 descriptions of changes: field g7: updated to "follow-up #: 1" field h2: entered "additional information" field h3: updated to "other", "device is not available for evaluation" field h6: updated result code to "3221".Updated conclusion code to "4315" field h10: added date of additional information received.Added descriptions of changes.

• 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
• MDR Report Key: 8240760
• MDR Text Key: 132938868
• Report Number: 9615030-2019-00001
• Device Sequence Number: 1
• Product Code: HJO
• Combination Product (y/n): N
• PMA/PMN Number: K143275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 700
• Device Catalogue Number: 000000-1932-169
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1