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

Model Number	ZA9003
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: not applicable as the product was not implanted.If explanted; give date: not applicable as the product was not implanted.Attempts were made to obtain missing information; however, to date no response was received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported the haptic of za9003 13.0 diopter intraocular lens (iol) was torn off.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Device available for evaluation?: yes.Returned to manufacturer: 10/15/2018.Date received by manufacturer: 11/13/2018.Device returned to manufacturer: yes.Device evaluated by manufacturer: yes.Device evaluation: the product was received at manufacturing site.The lens is missing a portion (iol torn) including a haptic.The detached portion of the lens was not returned.Other cosmetic damages are observed on the lens edge.The reported code of haptic damage was not verified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints was conducted, the search revealed no additional investigation requests have been received for this production order number.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.Conclusion: as a result of the investigation there is no indication of a product malfunction or 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
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION; 1700 e. st. andrew place; santa ana CA 92705
• MDR Report Key: 7988095
• Report Number: 2648035-2018-01372
• Device Sequence Number: 1190475
• Product Code: HQL
• UDI-Device Identifier: 05050474528871
• UDI-Public: (01)05050474528871(17)190423
• 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: health professional,user faci
• Initial Reporter Occupation: Nurse
• 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: 04/23/2019
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 11/08/2018; 10/25/2020
• Initial Report FDA Received Date: 10/20/2018
• Supplement Report FDA Received Date: 12/05/2018; 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