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 Patient Problem/Medical Problem (2688); Zonular Dehiscence (2698)

Event Date 05/18/2020

Event Type  Injury  

Manufacturer Narrative

The miloop was returned to the manufacturer and evaluated.The device was subjected to microscopic visual inspection which revealed the device to be in fair condition.There was minor physical damage sustained during transit (not preexisting) where the housing tube glue well was broken, but the wire loop was not distorted.The results showed the wire loop met visual specifications, met dimensional specifications, and passed functional testing.The investigation concluded that there was no discernable device deficiency that may have contributed to the event.The event was attributed to limited visibility of the capsulorhexis during device use.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, the event was attributed to use error and there is no evidence to indicate the presence of a potential quality issue with respect to manufacturing, design, or labeling.Tissue perforation is listed in the device labeling as an inherent risk of cataract surgery.Manufacturer's reference #: (b)(4).

Event Description

A female patient underwent cataract surgery in the right eye on (b)(6) 2020 where the miloop was used to section the cataractous lens into fragments.A malyugin capsular tension ring was used without issue.During the procedure, the surgeon inadvertently deployed the miloop anteriorly outside of the capsular bag and initiated the sweep; zonular dialysis occurred as a result of the device malposition and rotation.The surgeon stopped, rotated back and removed the miloop from the eye.An anterior vitrectomy was performed and a posterior chamber intraocular lens was implanted in the sulcus.The cataract was approximately grade 3 and there was no indication of preexisting weakened zonules.The case was reviewed afterwards with the surgeon, who attributed the event to compromised visibility of the capsulorhexis (excessive cortical material present); in retrospect, the surgeon thought trypan blue should have been used.Additional information was requested on 3 separate occasions, but no response was received.

• 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: andy rybold ; 8748 technology way; reno, nv ; 5959817
• MDR Report Key: 10150744
• MDR Text Key: 195303065
• Report Number: 3012123033-2020-00004
• 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: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2018
• 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