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

Model Number	ZKB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sections a-4 patient weight and a-5 patient ethnicity and race: unknown as information was not provided.Section b-3: date of event: unknown as information was not provided.The best estimate date is between (b)(6) 2023 and (b)(6) 2023 (iol implant and explant dates).Section h3-other (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.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 that an intraocular lens (iol) was implanted into the patient¿s ocular sinister (left eye).The iol was explanted in a secondary surgical procedure due to lens malfunction and replaced with a non-johnson & johnson surgical vision lens.There was no patient injury, no medical intervention, and no surgical intervention.Patient status post-lens exchange was reported as fine.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: 18-may-2023.Section h-3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received inside of a bag.Visual inspection under magnification revealed that the complaint lens was received cut in half and with a haptic detached.The lens was cleaned and, no further issues were observed with the lens.The remaining haptic was measured for haptic width and haptic thickness.The lens was within specification for both measurements.Complaint issue "dc-lens damage" was not identified during photo and product evaluation.The observed "dc-haptic damaged" is similar to the reported complaint issue (complaint coding may have been the result of the customer being unfamiliar with coding definitions per amo-04-d024).However, based on the complaint investigation results the complaint issue 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.A relationship between the device and the reported incident could not be determined.No product deficiency or product malfunction could be identified.Please note that the information reported in sections d-2 (common device name), section g-1 (manufacturer contact e-mail), and section h-6 health effect ¿ (clinical code and medical device problem code) is information that remains unchanged from the initial emdr report.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 16989926
• Report Number: 3012236936-2023-01244
• Device Sequence Number: 6343777
• Product Code: MFK
• UDI-Device Identifier: 05050474560215
• UDI-Public: (01)05050474560215(17)240317
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 06/10/2023

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: 03/17/2024
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0265
• 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: 04/28/2023
• Supplement Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 06/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female