MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS TORIC 1-PIECE; LENS, INTRAOCULAR, TORIC OPTICS

Model Number ZCT100

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 03/09/2021

Event Type  malfunction  

Manufacturer Narrative

Explant date: not applicable, as lens was not explanted.Initial reporter telephone number: (b)(6) it was indicated that the device is not returning for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.An attempt has been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the lens was implanted but a small white foreign material was noticed on lens.The lens was not explanted.It was confirmed that there was no toxic anterior segment syndrome (tass) nevertheless, medication was prescribed and given as a precaution.Patient came back second day and everything was clear.There was slight inflammation post op, but no treatment given, and patient is recovered on 2nd day post op.No further information available.

• Brand Name: TECNIS TORIC 1-PIECE
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; road 402 north, anasco ind. pk; anasco, PR 00610 ; 7142478552
• MDR Report Key: 11636219
• MDR Text Key: 244850319
• Report Number: 2648035-2021-07532
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 05050474537644
• UDI-Public: (01)05050474537644(17)231125
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2023
• Device Model Number: ZCT100
• Device Catalogue Number: ZCT1000235
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/10/2021
• Initial Date FDA Received: 04/08/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/25/2019
• 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