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

Lot Number FG22080110

Device Problem Use of Device Problem (1670)

Patient Problem Capsular Bag Tear (2639)

Event Date 10/26/2022

Event Type  Injury  

Manufacturer Narrative

For device not evaluated, the appropriate term/code would be device was discarded.

Event Description

Customer reported that during a cataract procedure while miloop was being removed from the eye, the doctor proceeded to utilize phaco to extract the hemispheres.Stop and chop was performed and as soon as he engaged the phaco pedal (almost in the identical location), ½ of first hemisphere dropped through the capsule exposing a hole in the anterior capsule.

• 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 ; 9255574100
• MDR Report Key: 15816501
• MDR Text Key: 303838392
• Report Number: 9615010-2022-00010
• Device Sequence Number: 1
• Product Code: HNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: FG22080110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female