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 Loss of Vision (2139); Zonular Dehiscence (2698)

Event Date 01/08/2019

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.The surgeon provided the following root cause insight.The surgeon thought she may have been able to stabilize the lens if she had been able to use a second instrument, but she was not certain if that would have been enough to prevent zonular dehiscence.The surgeon believed the patient's dense cataract, the decision not to use a second instrument to stabilize the lens, and potentially pre-existing weak zonules contributed to the 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.Zonular dehiscence is an inherent risk of cataract surgery.Manufacturer's reference #: (b)(4).

Event Description

A female patient with a very dense 3+ nuclear sclerotic cataract and history of diabetes underwent cataract surgery on (b)(6) 2019 where the miloop device was used to section the cataractous lens into quadrants.The miloop was introduced through a temporal clear corneal incision and the first miloop cut to bisect the lens appeared typical.According to the surgeon, during the second cut the crystalline lens rotated and she had difficulty repositioning the lens; at this point the posterior capsular bag was suspended.The surgeon was uncertain whether the posterior bag had ruptured, but she thought there may have been complete zonular dehiscence.The surgeon performed pars plana posterior-assisted levitation and lifted the lens into the anterior chamber.A sheets glide was inserted into the eye, and the nuclear fragments were removed from the anterior chamber using a lens loop.The surgeon then performed a vitrectomy and implanted an anterior chamber intraocular lens.There were no retained nuclear fragments, and the patient was not referred to a retinal specialist.The following surgical details were provided: the resident created the paracentesis in a non-optimal location before the attending surgeon took over to perform the miloop portion of the procedure.As she had already performed successful single-handed miloop cases on the same day, she did not feel the need to create a secondary incision in a more appropriate location.This circumstance precluded use of a second instrument to stabilize the nucleus during the case.The surgeon thought the patient possibly had weak zonules, although this was not noted preoperatively.One week postoperatively the surgeon reports an improvement in corneal edema and hand motion vision.The patient will be examined in 3 weeks.

Manufacturer Narrative

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

Event Description

Patient follow-up information was requested from the surgeon, who reported that the patient's bcva in the operative eye improved to 20/60 with trace temporal corneal edema.The patient also has mild macular degeneration, but had 20/40 best corrected vision preoperatively.

Event Description

Patient follow-up information was requested from the surgeon, who reported that the patient was definitely doing much better with diminished corneal edema, but still not back to baseline.

Manufacturer Narrative

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

• 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: 8315479
• MDR Text Key: 135384968
• Report Number: 3012123033-2019-00001
• 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,Followup
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2021
• Device Model Number: FG-11881
• Device Lot Number: FG20180502-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR