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

Model Number	ZCT600
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Vitrectomy (2643); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: exact date the lens dislocated is unknown, not provided.Best estimate is between 6/30/2016-9/22/2020.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens was explanted from the patient's left eye as it became dislocated.A non-johnson & johnson lens of 8.5 diopter was used as a replacement.There was no patient injury reported.No further information was provided.
Additional Manufacturer Narrative
Additional information: additional information received indicated that surgical interventions, intraocular lens (iol) exchange by flange intrascleral haptic fixation and anterior vitrectomy were involved.The following field was updated accordingly: section h6: additional patient code: 2643 - vitrectomy.Section d10.Device available for evaluation? yes; returned to manufacturer on: 10/21/2020 section h3.Device returned to manufacturer? yes.Device evaluation: the complaint lens was received in an unknown solution inside a specimen cup.Additional documentation was received as well.The lens was cleaned and 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 record review: the manufacturing process record was evaluated, and no deviation or nonconformance was found during process related to the complaint issue reported.The product was manufactured and released according to specifications.A search in complaint system revealed that no other complaints have been received for this production order number.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision 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: 10731626
• Report Number: 9614546-2020-00459
• Device Sequence Number: 11633715
• Product Code: HQL
• UDI-Device Identifier: 05050474604001
• UDI-Public: (01)05050474604001(17)210212
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2020

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: 02/12/2021
• Device Model Number: ZCT600
• Device Catalogue Number: ZCT600U120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL 1MTEC30, LOT: UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention