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

Model Number FG-11881

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/18/2019

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.According to the surgeon, the posterior capsule tear could have occurred at any one of three times during the procedure: during the original sweep with miloop (a single bisection was performed).During irrigation/aspiration.During lens insertion - it was noted that the iol did not exit the delivery cartridge in the proper orientation and had to be rotated into position with a second instrument.The surgeon's subsequent surgeries with the miloop were uneventful.Capsular bag damage is an inherent risk of cataract surgery.Manufacturer's reference #: (b)(4).

Event Description

A patient underwent cataract surgery in the right eye on (b)(6) 2019 where the miloop was used to section the cataractous lens into fragments.The surgeon noticed a tear in the posterior capsule after the intraocular lens was inserted into the capsular bag.An anterior vitrectomy was performed and the iol haptics were placed in the sulcus with the optic in the capsular bag; no sutures were required.The patient's one day postoperative visual acuity was 20/30.The relationship between the capsular damage and the miloop is not known.Additional information has been requested.

Manufacturer Narrative

Manufacturer's reference #: (b)(4).

Event Description

Postoperatively the patient is stable, the eye is quiet, and there was no loss of best corrected visual acuity.

• 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
• MDR Report Key: 9599340
• MDR Text Key: 189049080
• Report Number: 3012123033-2020-00001
• Device Sequence Number: 1
• Product Code: HNQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: FG-11881
• Device Lot Number: FG19072601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INTRAOCULAR LENS DELIVERY SYSTEM, INTRAOCULAR LENS; PHACOEMULSIFICATION EQUIPMENT
• Patient Outcome(s): Required Intervention