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

Model Number	PCB00
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: patient age and date of birth, patient weight, and ethnicity and race: unknown as information was asked but not provided.Date implanted: not applicable as the iol was not implanted.Date explanted: not applicable as the iol was not implanted.The device was not returned for analysis.Therefore, a visual 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 contact the account requesting additional information regarding the complaint.However; to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the pre-loaded intraocular lens (iol) misfired and was not usable.The back-up/new implant was used to finish the procedure.Patient outcome was provided as no negative impact reported.No further information was available.
Additional Manufacturer Narrative
Additional information received from product investigation: patient implant card received indicated patient's affected eye was ocular sinister (left eye).Product investigation was completed, and the following fields were updated accordingly: section d-9: device available for evaluation: yes.Section d-9: date returned to manufacturer: 23-may-2022.Section h-3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the handpiece was received with the lens stuck inside of the cartridge tip.Inspection of the handpiece body revealed that the screw was separated from the plunger rod.Observation of the iol inside of the cartridge revealed that it was stuck in the cartridge tip and that it had been torn.Creases on the lens from folding could also be identified.Complaint issue "uncontrolled delivery" was not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 14366208
• Report Number: 3012236936-2022-01230
• Device Sequence Number: 5640838
• Product Code: HQL
• UDI-Device Identifier: 05050474558366
• UDI-Public: (01)05050474558366(17)230123
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2022

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: 01/23/2023
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/27/2022
• Supplement Date Received by Manufacturer: 08/14/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2020
• 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
• Patient Sex: Unknown