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 03/26/2019

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.Capsular bag damage and vitreous loss are inherent risks of cataract surgery.Manufacturer's reference #: (b)(4).

Event Description

A (b)(6) female patient underwent cataract surgery in her right eye on (b)(6) 2019 where the miloop device was used to section the cataractous lens into quadrants.The case appeared typical through phacoemulsification, including the first lens sectioning, lens rotation with a drysdale nucleus manipulator (storz), and the second lens sectioning.After sectioning the second lens quadrant, a small capsular tear was observed when the miloop was removed from the eye.After phacoemulsification, a posterior capsular tear occurred parallel to the primary incision.Although the degree of vitreous loss was limited, an anterior vitrectomy was performed and a sulcus-fixated intraocular lens was implanted.The patient was reported as doing well at the one day postoperative visit.At the one week visit, there was some residual corneal edema and the patient's best corrected visual acuity (bcva) was 20/30 (no baseline provided); the patient reports feeling fine and happy.

• 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: jane demkovich ; 8748 technology way; reno, NV 89521 ; 7754731014
• MDR Report Key: 8530130
• MDR Text Key: 142462734
• Report Number: 3012123033-2019-00004
• 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: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2021
• Device Model Number: FG-11881
• Device Lot Number: FG20180510-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2018
• 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
• Patient Age: 76 YR