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

Model Number ZCU100

Device Problem Unstable (1667)

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

Event Date 01/25/2022

Event Type  malfunction  

Manufacturer Narrative

Age, weight and ethnicity: information unknown/not provided per country's personal data privacy legislation/policy.Explant date: not applicable, as lens remains implanted.Therefore, lens was not removed.(b)(6).Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing record evaluation: based on the manufacturing records review, and historical complaint review, there is no indication of a product malfunction or product quality deficiency.No nonconformity report, documentation or labeling changes, and escalations are required.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the zcu model intraocular lens (iol) was inserted into the patient's operative eye on (b)(6) 2022.Account indicated that anti-clockwise rotation around 40+ degrees was noticed when the surgeon was removing the ophthalmic viscoelastic device (ovd) using the phacoemulsification irrigation/aspiration (i/a) tip.Four (4) days later on (b)(6) 2022, lens was observed to have rotated 30 degrees anti-clockwise during post operative examination.It was revealed that the patient did not undergo reposition of the iol rotationally as patient does not like invasive procedures.No further information has been provided.

• Brand Name: TECNIS TORIC II
• 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: 13581864
• MDR Text Key: 291233664
• Report Number: 3012236936-2022-00477
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474691704
• UDI-Public: (01)05050474691704(17)251109
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZCU100
• Device Catalogue Number: ZCU100I190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2020
• 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