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

Model Number	ZCT600
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tecnis toric intraocular lens (iol) was implanted in the patient's operative eye when the surgeon observed a film adhered to the lens.The surgeon was able to remove the foreign material.It is uncertain if the film came from the lens itself or if it was in the cartridge.The lens remains implanted.Patient is ok.No further information was provided.
Additional Manufacturer Narrative
(race): unknown/ not provided.If implanted, give date: not applicable, as lens remains implanted.If explanted, give date: not applicable, as lens remains implanted.(b)(6).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.Attempts were made to obtain missing information; however, the account did not provide the information.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Additional Manufacturer Narrative
Corrected data: in reviewing the initial mdr, it was noticed that the implant date in section d6 was inadvertently not included; therefore, it is captured in this supplemental report: d6a.If implanted, give date: (b)(6) 2022.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: 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 ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 14636139
• Report Number: 3012236936-2022-01525
• Device Sequence Number: 17413997
• Product Code: MJP
• UDI-Device Identifier: 05050474604186
• UDI-Public: (01)05050474604186(17)240208
• Combination Product (Y/N): N
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/08/2024
• Device Model Number: ZCT600
• Device Catalogue Number: ZCT600U210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2022
• Supplement Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1MTEC30 CARTRIDGE LOT CJ35998
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 101 KG
• Patient Ethnicity: Hispanic