MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (OBERKOCHEN) MILOOP

Model Number 303071-9090-000

Device Problem Unintended System Motion (1430)

Patient Problem Hematoma (1884)

Event Date 03/04/2022

Event Type  malfunction  

Event Description

A zeiss sales representative who was present for 3 cataract surgeries with miloop reported that it was difficult to remove the loop after cut in two cases.The loop looked larger than usual.In the last case, the patient looked away nasally after loop was opened.The loop made contact with the iris underneath causing small hematoma.The doctor wanted to get the loop out immediately, but it was difficult due to the high friction of the slider.There was a little blood visible with the patient and the doctor expected it to be gone within a week.No injury reported for the patients from the first two cases.

Manufacturer Narrative

Review of the dhr showed that the affected batch was the first batch manufactured after implementation of three design changes.The root cause of the excess slider change was identified to be design and material change.A capa has been initiated to restore good slider performance.Description of changes: field b1: corrected to "product problem".Field g6: updated to "follow-up #: 1".Field h1 : corrected to "malfunction".Field h2 : selected "correction", "additional information".Field h6: updated investigation findings to " 174".Updated investigation conclusions to "12" field h10: added manufacturer narrative.Added description of changes.

• Brand Name: MILOOP
• Type of Device: MILOOP
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (OBERKOCHEN); rudolf-eber-strasse 11; oberkochen, baden-wuerttemberg 73447 ; GM 73447
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (OBERKOCHEN); rudolf-eber-strasse 11; oberkochen, baden-wuerttemberg 73447 ; GM 73447
• Manufacturer Contact: manjaya hegde ; 5300 central parkway; dublin, CA 94568 ; 9252164697
• MDR Report Key: 13981109
• MDR Text Key: 288472980
• Report Number: 9615010-2022-00002
• Device Sequence Number: 1
• Product Code: HNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 303071-9090-000
• Device Catalogue Number: FG-50608
• Device Lot Number: FG21082410
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/24/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 9615010-03-34-2022-001-R
• Patient Sequence Number: 1
• Patient Outcome(s): Other