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

Model Number	ZA9003
Medical Device Problem Codes	Break (1069); Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported an intraocular lens (iol) unfolded incorrectly, causing the iol to bend, rendering it unable to be used.The procedure was completed using another johnson & johnson lens with the same model and diopter size.The incision was enlarged and suture(s) were required however, there was no patient injury.Patient status post-procedure is unknown.No further information is available.
Additional Manufacturer Narrative
Sections a-4 patient weight and a-5 patient ethnicity and race: unknown/asked information unavailable.Section d6a: if implanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same procedure.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: 4625 incision enlargement and suture(s) section h-6 health effect - clinical code: 4581 incision enlargement an attempt was made to obtain missing information; however, the account did not have the information.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: 08-aug-2023.Section h-3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received in a specimen cup.The complaint lens was received cut in half.A damage loop, severed but not removed from the drill hole, was also observed.No additional defects before and after cleaning the lens was observed.Based on the return condition of the lens no further evaluation could be performed.Complaint issue " dc-unfolding issue" and ¿dc-lens damaged¿ was not confirmed during product evaluation.The observed issues during product evaluation could not be confirmed to be related to the manufacturing or design process.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.
Additional Manufacturer Narrative
Correction: during retrospective review of the file, it was noted this event was report was submitted as a serious injury event and malfunction which was incorrect.Since there was no patient injury, reported sutures can be considered standard procedure and the event is being updated as malfunction event only.The following has been updated accordingly: section b-1 report type product problem 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: 17386091
• Report Number: 3012236936-2023-01878
• Device Sequence Number: 12280188
• Product Code: HQL
• UDI-Device Identifier: 05050474529014
• UDI-Public: (01)05050474529014(17)250312
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/18/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/12/2025
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030200
• 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: 07/07/2023
• Supplement Date Received by Manufacturer: 08/25/2023; 12/07/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 08/29/2023; 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EMERALDC CARTRIDGE LOT: CK16877.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown