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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Visual Impairment (2138)

Event Type  Injury  

Event Description

A health care professional (hcp) reported that there had 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 will be performed to correct the patient's vision.

Manufacturer Narrative

Additional information received on 8/26/2019.Description of changes: field g7: updated to "follow-up #: 1" field h2: entered "device evaluation" field h3: updated to "evaluation summary attached" field h6: updated result code to "213".Updated conclusion code "4315".Field h10: added manufacturer narrative, added descriptions of changes, attached device evaluation summary - attachment: [mdr 9615030-2019-00006_ae iolmaster 700_ len exchange_us_ci1130134_fup_device evaluation.Pdf].

• 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: 8557835
• MDR Text Key: 143379650
• Report Number: 9615030-2019-00006
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

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: N/A
• Device Catalogue Number: 000000-2229-124
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/29/2019
• Initial Date FDA Received: 04/26/2019
• Supplement Dates Manufacturer Received: 03/29/2019
• Supplement Dates FDA Received: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention