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	Blurred Vision (2137); No Code Available (3191)
Date of Event	03/28/2018
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 tecnis toric intraocular lens (model zct225, +24.0 diopter) was explanted from patient¿s right eye in secondary procedure because of patient experiencing moderate blurry vision, unexpected post op refraction and pseudophakia.Reportedly model zct150, +25.5 diopter was used as replacement lens for the patient.Patient was recovering from the exchange.There was no incision enlargement.No further information provided.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: (b)(6) 2018.Device returned to manufacturer: yes device evaluation: the product was returned to the manufacturing site for evaluation.The product was inspected by a qualified final inspection operator using 12x magnification.It can be seen that the lens was damaged on both sides.The investigation does not suggest that the damage was produced during manufacturing.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints were received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be 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.; santa ana CA
• MDR Report Key: 7509319
• Report Number: 9614546-2018-00461
• Device Sequence Number: 19256619
• Product Code: HQL
• UDI-Device Identifier: 05050474552814
• UDI-Public: (01)05050474552814(17)190713
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2018
• 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: Physician
• Device Expiration Date: 07/13/2019
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT225U240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/13/2018
• Supplement Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 08/24/2018
• 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: 58 YR
• Date Report Sent to FDA: 01/01/2005