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

Model Number	ZCT300
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Blurred Vision (2137); Halo (2227); Discomfort (2330)
Date of Event	02/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens remains implanted.Device evaluation: the product testing could not be performed as lens remains implanted.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to specifications.The search revealed that no other complaints have been received for this production.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that model zct300 tecnis toric iol (intraocular lens) was placed at 98 degrees in the patient's right eye (od).At 1-month study visit, (b)(6) 2018, iol was measured at 115 degrees.This outcome did not affect patient's daily activities and there was no patient injury.There is no planned or performed treatment at this time.The lens remains implanted.The patient reported blurred and hazy vision when not wearing glasses or contacts.Mild physical discomfort related to eye was also noted in 1-month study visit.The patient had mild blurred, hazy vision and mild physical discomfort related to vision, which continued to persist.There were no other medical findings noted at this visit.The patient concluded his 6-month study visit.No further information 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.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7937058
• Report Number: 3011852734-2018-00181
• Device Sequence Number: 940648
• Product Code: HQL
• UDI-Device Identifier: 05050474553446
• UDI-Public: (01)05050474553446(17)210608
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/08/2017
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT300U260
• 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: 09/06/2018
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 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: Other
• Patient Age: 49 YR
• Date Report Sent to FDA: 01/01/2005