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

Model Number	ZCT300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); No Code Available (3191)
Date of Event	06/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported intraocular lens (iol) was implanted in the patient¿s ocular sinister (left eye) on (b)(6) 2019.The lens was explanted on (b)(6) 2020 due to complaints of blurred crooked visual acuity (va), and line of light at night.Va pre-operative was 20/70 and va post-operative was 20/25.There was no suture(s) and no vitrectomy.Patient outcome was reported as: myopia os.Through follow up, customer account provided additional information confirming the lens was replaced with a different model lens, higher diopter (21.0).No additional information was provided.
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 nr-0148919 and capa-010215.
Additional Manufacturer Narrative
Additional information was received, and the following fields were updated accordingly: section d-10: device available for evaluation: yes.Section d-10: returned to manufacturer on: 07/29/2020.Section h-3 device returned to manufacturer: yes.Device evaluation: the complaint lens was received inside a non-jnj lens case.Additionally, a complaint intake form was received as well.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptics, and that the lens was received cut in half, which is consistent with a lens that was handled during explant.Furthermore, a haptic was observed stuck to the optic body, however this can be attributed to the lens being returned cut in half and the dry viscoelastic residue on the haptic and optic body.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.

• 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: 10318611
• Report Number: 9614546-2020-00264
• Device Sequence Number: 19796856
• Product Code: HQL
• UDI-Device Identifier: 05050474553309
• UDI-Public: (01)05050474553309(17)200510
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2020
• 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: 05/10/2020
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT300U190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 08/02/2020; 10/25/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 08/20/2020; 10/29/2020
• 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
• Patient Age: 67 YR
• Date Report Sent to FDA: 01/01/2005