MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION TECNIS CL; MONOFOCAL IOLS

Model Number	Z9002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.If implanted; give date: not applicable as the iol was not implanted.If explanted; give date: not applicable as the iol was not implanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported when inserting a model z9002, 22.5 diopter intraocular lens (iol), the haptic was crimped.The lens was not implanted in the patient's eye.Through follow-up, customer confirmed the cartridge tip had patient contact.There was no incision enlargement, no serious patient injury, no suture(s), and no vitrectomy.The procedure was completed successfully using the backup lens, same model and size.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Device evaluation: the product return was received on 11/30/2018, which revealed viscoelastics and /or balanced salt solution observed on the lens surface; indicating that the lens was handled to be prepared for insertion.The haptics are not distorted/crimped as described on the initial report.The reported issue was not verified.A product quality deficiency could not be determined.Manufacturing record review: manufacturing record review of the production order and related document revealed that the product was manufactured and released according to specifications.A search in complaint history was performed which revealed that no similar complaint has been received for this production order number.Labeling review: the labeling review was completed.The directions for use (dfu) adequately provide instructions, precautions, along with warnings for the proper use and handling of the product.Conclusion: 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.
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 CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION; santa ana CA 92705
• MDR Report Key: 8086078
• Report Number: 2648035-2018-01494
• Device Sequence Number: 19262600
• Product Code: HQL
• UDI-Device Identifier: 05050474530744
• UDI-Public: (01)05050474530744(17)220711
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2020
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/11/2022
• Device Model Number: Z9002
• Device Catalogue Number: Z900200225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 12/17/2018; 10/25/2020
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 01/11/2019; 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005