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

Model Number	ZCT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Therapeutic Effects, Unexpected (2099); Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	08/27/2020
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 that the patient has residual myopia and astigmatism post implantation.The patient also has imbalance (anisometropia).The patient complained of having ongoing difficulty seeing post-operatively.Vision in left eye worse with night driving.Visual acuity (va) pre-op: was not provided.Visual acuity post-op: -1.50 + 1.00.Therefore, the patient was scheduled for an intraocular lens (iol) exchange.Through follow-up, it was learned the patient had a loss of 2 or more lines best spectacle corrected visual acuity (bscva) or 2 or more diopters.The patient has a history of astigmatism.And the va negatively impacted the patient.Therefore, the lens was explanted from the left eye.There was no incision enlargement/unplanned sutures/vitrectomy required.Another johnson & johnson lens (different model and lower diopter) was successfully implanted as a replacement.The patient was doing well at discharge.No additional information was provided.
Additional Manufacturer Narrative
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 submerged in an unknown solution inside a specimen cup.A completed jjsv customer returns guide was received as well.Visual inspection under magnification revealed that the lens was returned cut in pieces (not all pieces received), which is consistent with a lens that was handled during explant.Based on the returned 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 records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be confirmed.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: 10673164
• Report Number: 9614546-2020-00449
• Device Sequence Number: 14135154
• Product Code: HQL
• UDI-Device Identifier: 05050474552685
• UDI-Public: (01)05050474552685(17)220326
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/26/2022
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT225U175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Received by Manufacturer: 09/18/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 11/24/2020
• 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: 62 YR