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

Model Number FG-11881

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643); Foreign Body In Patient (2687)

Event Date 08/12/2019

Event Type  Injury  

Manufacturer Narrative

The device was returned to the manufacturer and the evaluation is in process; the findings will be reported in a supplemental report.The device history records were reviewed for this manufacturing lot and there were no discrepancies or unusual findings that relate to the reported event.Capsular bag damage, vitreous loss, and dropped nuclear fragments are inherent risks of cataract surgery.[reference: schaal s, nesmith blw, ihnen ma, al-latayfeh m.Current medical and surgical management of retained lens fragments after cataract extraction.Us ophthalmic review 2014;7(2):95-99.] manufacturer's reference #: (b)(4).

Event Description

A patient underwent cataract surgery on (b)(6) 2019 where the miloop was used to section the cataractous lens into fragments.The lens was successfully bisected with the miloop using proper technique and the surgeon proceeded with phacoemulsification.During phacoemulsification, vitreous fluid was lost from underneath the lens nucleus and the surgeon reported that the posterior capsule had ruptured.An anterior vitrectomy was performed and it was observed that some of the lens nucleus and cortex had dropped posterior.The surgeon was unclear what caused the posterior capsule to tear and wondered if the miloop may have caught on something behind the nucleus.The patient was referred to a retina specialist to retrieve the lens fragments.Additional information has been requested.

Manufacturer Narrative

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

Event Description

The company representative provided the following details concerning the initial cataract surgery.The patient had discontinued flomax several months prior to surgery, however, the surgeon mentioned the iris was still affected (floppy iris syndrome).During phacoemulsification (after the miloop had been removed from the eye), the iris started coming down so the surgeon made several paracentesis incisions and placed iris hooks.During subsequent phacoemulsification and anterior vitrectomy, the iris prolapsed through the incision located at the 3:00 position.The iris was pushed back into the incision and a single suture was placed; however, the iris continued to prolapse through the paracentesis and eventually detached in that quadrant.The iris prolapse and subseqent damage is related to the patient's floppy iris syndrome and is not believed to be associated with the miloop device.

Manufacturer Narrative

The device was returned to the manufacturer, decontaminated, and subjected to visual inspection and mechanical functional testing.The visual examination performed prior to decontamination revealed the device was received improperly packaged and had become damaged (bent wire and bent housing tube) during transit.Despite the device damage, the miloop passed functional testing and was able to travel the full range of movement, extending to full length and retracting to full retraction.The cause of the event remains undetermined.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.Manufacturer's reference #: (b)(4).

Event Description

The following additional information was provided by the surgeon.Iris hooks were used during cataract surgery and a portion of the iris prolapsed through one of the iris hook incisions.During the vitrectomy, a portion of iris that had prolapsed detached.

• 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: 8996817
• MDR Text Key: 161335652
• Report Number: 3012123033-2019-00007
• 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: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2022
• Device Model Number: FG-11881
• Device Lot Number: FG19031910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Date Manufacturer Received: 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PHACOEMULSIFICATION EQUIPMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR