MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION TECNIS 1-PIECE; MONOFOCAL IOLS

Model Number	ZCB00
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pt info: unknown, information not provided.Implant and explant dates: if implanted or explanted; give date: not applicable as the product was not implanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported when removing a zcb00 9.5 diopter intraocular lens (iol) from packaging customer account reported a scratch was noticed on the iol upon opening.Through follow up, customer account provided additional information confirming no patient contact, confirmed out of box failure and product was not handled.The procedure was completed successfully using the backup lens of the same model and diopter size.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 10/22/2018.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.The lens was observed under microscope 10x magnification and viscoelastic residue was observed.The lens was cleaned to identify the complaint reported.No damage, scratches, or additional cosmetic defects were observed.The complaint issue was not confirmed.A product deficiency could not be determined.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search in the complaint database was conducted.Results revealed one additional complaint for this production order number.This complaint was not related to this issue and no product deficiency was identified.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.
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 1-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION; 1700 e. st. andrew place; santa ana CA 92705
• MDR Report Key: 8027048
• Report Number: 2648035-2018-01411
• Device Sequence Number: 16469292
• Product Code: HQL
• UDI-Device Identifier: 05050474531505
• UDI-Public: (01)05050474531505(17)190924
• Combination Product (Y/N): Y
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• 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): 11/04/2020
• 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: 09/24/2019
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/02/2018
• Supplement Date Received by Manufacturer: 11/02/2018; 10/25/2020
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 11/24/2018; 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