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

Model Number	ZCT525
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	08/15/2018
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 the zct525 7.0 diopter intraocular lens (iol) was implanted into the patient's right eye (od) on (b)(6) 2018.One day post-op the patient had a refraction surprise of approximately +1.50 cylinder.Reportedly, the patient had blurry vision at distance that significantly interfered with activities of daily life.Pre-op: corrected visual acuity 20/30; post-op: 20/100.The lens was explanted on (b)(6) 2018.No patient injury was reported.No additional information was provided.
Additional Manufacturer Narrative
Device evaluation: the intraocular lens (iol) was not returned to the manufacturing site for evaluation.The customer''s reported complaint could not be confirmed.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no other complaints have been received or 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.Device evaluated by mfr: 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 nr-0148919 and capa-010215.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7876174
• Report Number: 9614546-2018-00891
• Device Sequence Number: 16177067
• Product Code: HQL
• UDI-Device Identifier: 05050474603318
• UDI-Public: (01)05050474603318(17)221012
• Combination Product (Y/N): Y
• Initial Reporter State: MS
• 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: 2018
• 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: 10/12/2022
• Device Model Number: ZCT525
• Device Catalogue Number: ZCT525U070
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 10/10/2018; 10/25/2020
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 11/06/2018; 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
• Patient Age: 67 YR
• Date Report Sent to FDA: 01/01/2005