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

Model Number	ZCU300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: sections a-4 patient weight and a-5 patient ethnicity and race: unknown/asked information unavailable.Section d-6a date implanted: not applicable as the iol was removed and replaced during the same procedure.Section d-6b date explanted: not applicable as the iol was removed and replaced during the same procedure therefore not explanted.Section h3-81: the device was not returned for evaluation.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.Section h-6 health effect - impact code: 4631 iol removal and replacement attempts were made to contact the customer account requesting additional information regarding 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 the plunger of the loader made a hole in the zcu300 model intraocular lens (iol) upon insertion.The iol was fully inserted into the patient¿s ocular dexter (right eye).During the same procedure, the iol was removed and replaced, with another zcu300 20.5 diopter iol.There was no incision enlargement, no serious patient injury, no suture(s), and no vitrectomy.Patient status post-procedure in unknown.No further information is available.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: yes, section d-9: device date returned to manufacturer: 15-jun-2023, section h-3: device evaluated by manufacturer: yes, device evaluation: the iol was received in the daisy wheel.The lens was cleaned and visual inspection under magnification was performed.No issues were identified with the lens, and no further evaluation was performed.Complaint issue "dc-lens damaged" could not be confirmed during product evaluation, and no issues were identified.Conclusion: based on the complaint investigation results, the product was released within specifications.The complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.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: 17052288
• Report Number: 3012236936-2023-01380
• Device Sequence Number: 6984739
• Product Code: HQL
• UDI-Device Identifier: 05050474660168
• UDI-Public: (01)05050474660168(17)250616
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2023

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: 06/16/2025
• Device Model Number: ZCU300
• Device Catalogue Number: ZCU300U205
• 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: 05/12/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2020
• 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: Male