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

Model Number	ZA9003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	07/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown, information was requested but not provided.If explanted, give date: not applicable as the lens remains implanted.The device is not returning for evaluation as the lens 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.An attempt has been made to obtain the missing information; however, to date, the information has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an incorrect intraocular lens (iol), model zcb00, 27.5 diopter was fully inserted into the left eye of a patient.The lens was removed and a different johnson and johnson lens, model za9003, 19.0 diopter was implanted during the same procedure.After the replacement lens was inserted capsule tear occurred; therefore, a vitrectomy was performed.No other interventions were mentioned.The daily activities of the patient were not significantly affected.The patient has recovered.No further information was provided.

• Brand Name: TECNIS IOL
• Common Device Name: 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: 15331832
• Report Number: 3012236936-2022-02311
• Device Sequence Number: 12383842
• Product Code: HQL
• UDI-Device Identifier: 05050474528994
• UDI-Public: (01)05050474528994(17)240708
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2024
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030190
• 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: 08/03/2022
• Initial Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2019
• 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 CJ28424
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female