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

Model Number	ZCT150
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is during (b)(6) 019- (b)(6) 2020.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was explanted from patient's left eye due to iol rotated as well as the power was off, and specific visual issues.The lens was replaced with a model zcu 19.5 diopter lens.No problems with patient post-op.No further information provided.
Additional Manufacturer Narrative
Additional information: section d10: device available for evaluation: yes, returned to manufacturer on 4/8/2020.Section h3: device returned to manufacturer: yes.Device evaluation: the lens was received in a specimen cup.Additionally, documentation was received with scanned images of the original patient stickers.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptics, a detached haptic, and a cut through the lens (lens not separated), 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 reported complaint issue could not be confirmed, and no product deficiency was identified.The reported complaint issue could not be confirmed and no product deficiency was identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that one complaint for this order number have been received and is not related to the complaint issue reported for this investigation.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, inc.Has been submitted.H3 other text : placeholder.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are (b)(4) and capa-010215.

• 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: 9851738
• Report Number: 9614546-2020-00132
• Device Sequence Number: 2921580
• Product Code: HQL
• UDI-Device Identifier: 05050474552128
• UDI-Public: (01)05050474552128(17)220610
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2020
• Report Date (Section F): 01/01/2005

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: 06/10/2022
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 04/21/2020; 10/25/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 04/22/2020; 11/03/2020
• 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
• Date Report Sent to FDA: 01/01/2005