MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS TORIC; INTRAOCULAR LENS

Model Number UNK-ZCU375

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.

• Brand Name: TECNIS TORIC
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• 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: HQL
• 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-ZCU375
• Device Catalogue Number: UNK-ZCU375
• 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