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

Model Number	ZCT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Date of Event	03/20/2019
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 that post implant of a model zct150 21.5 diopter intraocular lens (iol) into the patient¿s left eye, there was hyperopic surprise.The iol was still on axis showing refraction of +1.50 -1.25 x 71, hyperopia had gradually increased since the iol was implanted in the eye.The patient experienced blurry double vision in both distance and near vision.The lens was subsequently explanted and replaced with a model zct225 22.5 diopter lens.At explant it was reported an incision enlargement was required, however later information provided stated there were no complications.Patient outcome post exchange was not provided.Visual acuity pre-operative 20/60.Visual acuity post-operative 20/40+1.No further information provided.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 5/17/2019.Device returned to manufacturer: yes.Device evaluation: the product was received dry in a jar.The product was disinfected according to procedure wv0491.The product was inspected by a qualified inspector using a microscope with 12x magnification it can be seen that the lens is damaged by tweezers on both sides of the lens.No other anomalies were 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 no similar complaints were received for this production order number.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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.
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: 8592097
• Report Number: 9614546-2019-00434
• Device Sequence Number: 11347897
• Product Code: HQL
• UDI-Device Identifier: 05050474552173
• UDI-Public: (01)05050474552173(17)200510
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2020
• 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: ZCT150
• Device Catalogue Number: ZCT150U215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 05/28/2019; 10/25/2020
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 06/20/2019; 11/12/2020
• 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: 83 YR
• Date Report Sent to FDA: 01/01/2005