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

Model Number	ZA9003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: unknown, information not provided.If explanted, give date: unknown, information not provided.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson vision has been submitted.
Event or Problem Description
It was reported that tecnis monofocal intraocular lens (model za9003 +14.0 diopter) had defective haptic.There was patient contact.No further information provided.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 11/20/2018.Device returned to manufacturer: yes.Device evaluation: the returned za9003 lens was received in the original box, inside the lens case.The lens was observed under microscope 10x magnification: viscoelastic residues and marks were observed in the optic zone.Part of the optic zone was observed broken and missing.One of the haptic was observed distorted.The complaint was verified; however, the condition of returned sample could be related to handling or loading process.No product quality deficiency was identified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other complaint has been received for this production order.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.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 nr-0148919 and capa-010215.

• Brand Name: TECNIS
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7982563
• Report Number: 2648035-2018-01348
• Device Sequence Number: 11108001
• Product Code: HQL
• UDI-Device Identifier: 05050474528895
• UDI-Public: (01)05050474528895(17)190826
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2020
• 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: 08/26/2019
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 12/06/2018; 10/25/2020
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 12/07/2018; 11/04/2020
• 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