MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number UNK-ZXT

Device Problems Unstable (1667); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Section d4: model number: unknown, as the serial number was not provided.Only provided as (b)(6).Section d4: catalog number: a complete catalog number is unknown, as the serial number was not provided.Only provided as (b)(6).Section e1: telephone number: (b)(6).Section h3-other (81): the device was not returned for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Section h4: device manufacture date: unknown, as the serial number was not provided.Attempts have been made to obtain missing information; however, there is no additional information available.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a toric multifocal intraocular lens (iol) rotated counter clockwise 23 degrees.Through follow up, it was learned that it was a toric monofocal zcu375 lens model and not a toric multifocal lens.The surgeon indicated that the serial number (sn) is not available.The lens was surgically rotated 8 weeks after implantation with a 20/25+3 uncorrected result.The lens remains implanted.No other information is available.

Manufacturer Narrative

Corrected data: further information was provided and the surgeon clarified that a total of two patients who had large rotations.The first patient was reported over a year ago (captured in (b)(6), under manufacturer report number 3012236936-2024-00355).The second patient had surgery in december of 2023 who definitely had a zcu iol (captured in (b)(6), under manufacturer report number 3012236936-2024-00597).The surgeon indicated that he cannot recall the former (first) patient's iol model as it's been so long ago.The surgeon stated he is not even sure he kept the name of the patient.He recalls he was noting the incident on the day of the surgery, if the patient was close to being on target or off target.However, the surgeon reported he did not track the event in any formal sense.The surgeon clarified that the second patient with the large rotation occurred with the zcu iol model.Therefore, updating this event iol model to an unk-zxt as a zxt iol was what the surgeon originally reported on (b)(6) 2023.No further information is available.The following sections have been updated accordingly: section d1: brand name: (b)(6).Section d4: model number: unk-zxt.Section d4: catalog number: a complete catalog number is unknown, as the serial number was not provided.Only provided as zxt.Manufacturing record review: the manufacturing record could not be reviewed since the serial number was not provided.Conclusion: based on the limited information provided, it is not possible to determine an indication of product malfunction or product deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Type of Device: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen PR 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 18707687
• MDR Text Key: 335453709
• Report Number: 3012236936-2024-00355
• Device Sequence Number: 1
• Product Code: POE
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK-ZXT
• Device Catalogue Number: UNK-ZXT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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