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

Model Number 700

Device Problem Use of Device Problem (1670)

Patient Problem Visual Impairment (2138)

Event Date 05/02/2019

Event Type  Injury  

Manufacturer Narrative

The hcp was selecting a lens on pattern recognition (top left box of printout sheet) rather than reading the information within the box.Due to a (probably unintended) change of the drop-down list of iols, the sequence of iols on the printout sheet changed.In some cases, the change had been noticed and a different box (not the top left) was highlighted by the physician for lens selection, however in some cases it was not.This resulted in some patients being implanted not with the ideal iol.

Event Description

A health care professional (hcp) reported that there had been four patients with incorrect surgical results after using the iolmaster 500 for the biometry measurements and lens power calculations.The hcp reported that one patient required additional medical intervention to correct impaired vision.

Manufacturer Narrative

The healthcare provider (hcp) was selecting a lens on pattern recognition (top left box of printout sheet) rather than reading the information within the box.Due to a (probably unintended) change of the drop-down list of iols, the sequence of iols on the printout sheet changed.In some cases, the change had been noticed and a different box (not the top left) was highlighted by the physician for lens selection, however in some cases it was not.This resulted in some patients being implanted not with the ideal iol.Descriptions of changes: field g1-2: updated to "contact office", field g7: updated to "follow-up #: 1", field h2: updated to "additional information" , field h3:updated to "other", field h6: added health effect - impact code.Added component code.Updated investigation findings code to "213".Updated investigation conclusions code to "18," and "4310".Field h10: added additional manufacturer narrative and descriptions of changes.

• 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, 7745 ; GM 7745
• MDR Report Key: 9662729
• MDR Text Key: 178134205
• Report Number: 9615030-2020-00003
• Device Sequence Number: 1
• Product Code: HJO
• Combination Product (y/n): N
• PMA/PMN Number: K122418
• 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: 01/10/2020

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 Model Number: 700
• Device Catalogue Number: 000000-1692-983
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/10/2020
• Initial Date FDA Received: 02/03/2020
• Supplement Dates Manufacturer Received: 01/10/2020
• Supplement Dates FDA Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention