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

Model Number	ZKB00
Medical Device Problem Code	Application Program Problem: Dose Calculation Error (1189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Ethnicity: unknown.The device was returned for evaluation.However the investigation is in process.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported the zkb00 20.5 diopter intraocular lens (iol) was implanted into the patient¿s ocular sinister (left eye).The iol was explanted in a secondary surgical procedure due to complaints of wrong power implanted and replaced with a zkb00 20.0 diopter iol.There was no medical and no surgical intervention during the surgery.Patient outcome post op was reported as patient happy, 20/20- mr: -0.50 +0.50 x 155.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: yes.Section d-9: date returned to manufacturer: 14-feb-2023.Section h-3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed the lens was cut in half and coated in viscoelastic residue.The lens was cleaned and further inspected under magnification and damage on the lens was identified where the outside of the optic meets the spare tire portion of the lens.No further issues were identified.Complaint issues were not confirmed.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.A search revealed that no other complaints have been received for this production order (po) number.Conclusion: based on the investigation results, there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.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: 16433173
• Report Number: 3012236936-2023-00476
• Device Sequence Number: 3126860
• Product Code: MFK
• UDI-Device Identifier: 05050474560093
• UDI-Public: (01)05050474560093(17)260813
• 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: 2022
• 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): 03/16/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/13/2026
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2023
• 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: 02/01/2023
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2022
• 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: Male
• Patient Weight: 102 KG
• Patient Race: White