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 04/22/2019

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, 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.Capsular bag damage 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 in the right eye on (b)(6) 2019 where the miloop was used to section the cataractous lens into fragments.After the first lens sectioning with the miloop, the surgeon had difficulty rotating the lens so company personnel suggested to the surgeon that one cut was sufficient and recommended not proceeding with a second cut.However, the surgeon elected to perform a second cut and inadvertently inserted the miloop too far posteriorly with the tip of the housing tube beyond the center of the capsule and the posterior capsule subsequently ruptured.Half of the lens dislocated into the vitreous and the other half was removed with anterior vitrectomy.A three-piece intraocular lens was implanted uneventfully and the patient was referred to a retina specialist to retrieve the lens fragment.Additional information was requested from the surgeon, who reports that retinal surgery was performed on (b)(6) 2019.The patient's initial postoperative best corrected visual acuity (bcva) was 20/40, improving to 20/30 at last examination on (b)(6) 2019.

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: 8620833
• MDR Text Key: 145411871
• Report Number: 3012123033-2019-00005
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2021
• Device Model Number: FG-11881
• 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
• Patient Outcome(s): Required Intervention