MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS; TORIC IOLS

Model Number	ZCT600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: age/date of birth: unknown.(b)(4).Attempts have been made to obtain missing information; 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
Customer reported that the patient experienced unexpected postop refraction/not optimal vision post-implant of an intraocular lens (iol).The iol was explanted from the patient's left eye.The incision was not enlarged.The outcome does not significantly interfere with activities of daily life, and the patient has recovered.No further information was provided.
Additional Manufacturer Narrative
Correction: in the initial medwatch# 9614546-2020-00440, section d4 reported zct300.It is updated to zct600.Additional information: device evaluation: product testing could not be performed as the product was not returned.The reported event could not be verified 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 specifications.A search revealed that no similar complaints were received for this production order.Conclusion: based on the investigation, no product deficiency was identified.Correction: in the initial medwatch# 9614546-2020-00440, section d4 reported zct300.It is updated to zct600.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d10: device available for evaluation: yes.Section d10: returned to manufacturer on: 1/06/2021.Section h3: device returned to manufacturer: yes.Device evaluation: the product was subsequently returned to the manufacturing site for evaluation.The complaint lens was received stuck to the inside of an opened inner pouch.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptics, and the lens cut in half, which is consistent with a lens that was handled during explant.Furthermore, fibers were observed on the lens, which can be attributed to receiving the lens stuck to paper side of the opened inner pouch it was received.Based on the return condition of the lens, no further product evaluation could be performed and no product deficiency could be identified.The reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10609879
• Report Number: 9614546-2020-00440
• Device Sequence Number: 14049838
• Product Code: HQL
• UDI-Device Identifier: 05050474604209
• UDI-Public: (01)05050474604209(17)230607
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/08/2021

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: 06/07/2023
• Device Model Number: ZCT600
• Device Catalogue Number: ZCT600U220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 11/12/2020; 01/19/2021
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 11/17/2020; 02/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention