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 Vitreous Loss (2142); Capsular Bag Tear (2639); Vitrectomy (2643)

Event Date 03/13/2019

Event Type  Injury  

Manufacturer Narrative

The device was discarded by the user facility and is 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.Based on the information reviewed, there is no evidence to indicate the presence of a potential quality issue with respect to manufacturing, design, or labeling.The relationship between the event and the device is unknown and no surgical video is available for analysis.Capsular bag damage and vitreous loss are inherent risks of cataract surgery.Manufacturer's reference #: (b)(4).

Event Description

A (b)(6) year-old female patient with a grade 3+ nuclear sclerotic cataract underwent cataract surgery on (b)(6) 2019 where the miloop device was used to section the cataractous lens into quadrants.After the first successful bisection, the surgeon removed the miloop from the eye, rotated the lens with a drysdale nucleus manipulator (storz), then reinserted the miloop and made the final lens cut.After removing the first 2 lens quadrants, the surgeon noticed a small posterior capsule tear at the 9:00 position (left eye, temporal incision) and vitreous loss.A vitrectomy was performed and a sulcus-fixated intraocular lens was implanted.Additional information has been requested.

Manufacturer Narrative

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

Event Description

Patient follow-up information was requested from the surgeon and the clinic reported that the patient's bcva in the operative eye was 20/20-2 at last examination on (b)(6) 2019.

• 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: 8452743
• MDR Text Key: 139878948
• Report Number: 3012123033-2019-00003
• 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: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2021
• Device Model Number: FG-11881
• Device Lot Number: FG20180514-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DRYSDALE NUCLEUS MANIPULATOR (STORZ); DRYSDALE NUCLEUS MANIPULATOR (STORZ)
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR