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

Model Number FG-11881

Device Problem Use of Device Problem (1670)

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643)

Event Date 01/14/2020

Event Type  Injury  

Manufacturer Narrative

The device was discarded by the user facility and was not available for evaluation.The device history records were reviewed for this manufacturing lot and there were no discrepancies or unusual findings that relate to the reported event.Capsular bag damage is listed in the device labeling as an inherent risk of cataract surgery.Manufacturer's reference #: (b)(4).

Event Description

A male patient underwent cataract surgery in the left eye on (b)(6) 2020 where the miloop was used to section the cataractous lens into fragments.During the miloop portion of the procedure, the surgeon elected to bisect the lens without using a second instrument and the lens prolapsed into the anterior chamber.As the lens prolapsed, the capsular bag tore.The lens was removed, an anterior vitrectomy was performed, and the case was completed.The patient was reported as doing well postoperatively.Additional information was requested from the surgeon on (b)(6) 2020 to understand the relationship between the capsular damage and the miloop.The size of the capsulorhexis was approximately 4-5 mm and the cataract grade was estimated at 2+.The surgeon attributed the event to use error and there was no problem with the miloop device.

• 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
• Manufacturer (Section G): CARL ZEISS MEDITECH CATARACT TECHNOLOGY, INC.; 8748 technology way; reno, nv
• Manufacturer Contact: ed conley ; 8748 technology way; reno, nv ; 3797261
• MDR Report Key: 9700966
• MDR Text Key: 189037301
• Report Number: 3012123033-2020-00002
• 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: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2021
• Device Model Number: FG-11881
• Device Lot Number: FG20181207-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2018
• 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