MAUDE Adverse Event Report: CARL ZEISS MEDITEC CATARACT TECHNOLOGY, INC. MILOOP LENS FRAGMENTATION DEVICE; OPHTHALMIC HOOK

Model Number FG-11881

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Zonular Dehiscence (2698)

Event Date 07/23/2019

Event Type  Injury  

Manufacturer Narrative

Based on the information reviewed, the event was attributed to use error and there is no evidence to indicate the presence of a potential quality issue with respect to manufacturing, design, or labeling.Zonular damage is an inherent risk of cataract surgery.Manufacturer's reference #: (b)(4).

Event Description

A patient underwent cataract surgery on (b)(6) 2019 where the miloop was intended to be used to section the cataractous lens into fragments.The company representative in attendance noted the surgeon experienced some difficulty inserting the miloop through the incision.Once the miloop was deployed, the surgeon was unable to rotate the wire loop.Upon microscopic examination, it was revealed that the device was not inserted to the proper depth (too anterior/shallow).The surgeon was unable to advance the miloop, so it was retracted and removed from the eye.The surgeon elected not to proceed with the miloop and the cataract was fragmented using phacoemulsification.After several minutes, the surgeon reported there was zonular damage and a capsular tension ring was inserted.The relationship between the zonular damage and the miloop is unknown.Additional information is being requested.

• Brand Name: MILOOP LENS FRAGMENTATION DEVICE
• Type of Device: OPHTHALMIC HOOK
• Manufacturer (Section D): CARL ZEISS MEDITEC CATARACT TECHNOLOGY, INC.; 8748 technology way; reno NV 89521
• Manufacturer (Section G): CARL ZEISS MEDITEC CATARACT TECHNOLOGY, INC.; 8748 technology way; reno NV 89521
• Manufacturer Contact: ed conley ; 8748 technology way; reno, NV 89521 ; 7754731014
• MDR Report Key: 8923990
• MDR Text Key: 155327540
• Report Number: 3012123033-2019-00006
• Device Sequence Number: 1
• Product Code: HNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FG-11881
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: PHACOEMULSIFICATION EQUIPMENT
• Patient Outcome(s): Required Intervention