MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	ZCT300
Medical Device Problem Codes	Break (1069); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Ethnicity and race: unknown as information was not provided.The device was manufactured at the kulim site, which has been closed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported the intraocular lens (iol) was implanted in the patient's ocular sinister (left eye) on (b)(6) 2020.The iol was explanted (b)(6) 2021 due to scratch on lens.Planned vitrectomy was performed.There was no patient injury and it was reported the patient is doing fine post-operatively.Through follow-up, additional information was received confirming the incision was enlarged and suture(s) used during the explant procedure were planned.The explanted lens with replaced a non-johnson & johnson surgical vision lens.No further information is available.
Additional Manufacturer Narrative
Additional information was received, and the following fields were updated accordingly: section d-9: device available for evaluation: yes.Section d-9: date returned to manufacturer: 15-apr-2021.Section h-3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the lens was received cut in half, which is consistent with a lens that was handled during explant.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue could not be confirmed and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search revealed that no other complaints for this production order number have been received.Conclusion: as a result of the investigation, 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.
Additional Manufacturer Narrative
Corrected data: section h6: as part of an internal review of our mdrs it was identified that the device code 1069 provided on the initial report needs to be corrected.Device code 1069 is no longer applicable.The correct device code is code is 3020 cosmetic issues.The following section has been updated accordingly: section h6: medical device problem code: 3020 cosmetic issues.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.Note: acknowledgement 2 for this report was received on 9/22/2022.There was a delay in receiving acknowledgement 3 due to a cdrh system issue.Multiple follow-ups were conducted with the esg help desk.On 10/18/2022 esg responded requesting to resubmit the mdr.Therefore, this report is being resubmitted on 10/19/2022.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e. st andrew place; santa ana CA 92705
• Manufacturer Contact: somyata nagpal ; 1700 e. st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 11633404
• Report Number: 2020664-2021-07017
• Device Sequence Number: 3683468
• Product Code: MJP
• UDI-Device Identifier: 05050474553279
• UDI-Public: (01)05050474553279(17)220605
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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,Followup
• Report Date (Section B): 10/19/2022

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: 06/05/2022
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT300U175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 04/27/2021; 08/28/2022
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 05/26/2021; 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2018
• 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 Age: 61 YR
• Patient Sex: Male
• Patient Weight: 98 KG