MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. 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	01/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: n/a (not applicable).No patient involvement.If explanted; give date: n/a (not applicable).No patient involvement.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zcb00 11.5 diopter intraocular lens (iol) was scratched when removing from the packaging.There was no patient involvement.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation: yes, returned to manufacturer on: 2/14/2019, device returned to manufacturer: yes.Device evaluation: the lens was returned in the original lens case insert.The sample was evaluated and observed in good condition and has particles that suggest that the lens was handled out of the sterile environment.The manufacturing data confirms no process deviations that may lead to visible damaged deposition on the iol that may be undetected by our control process.Based on the product returned evaluation, neither a product quality deficiency nor a product malfunction could be determined.The complaint issue reported was not verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.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.Historical data analysis: a search of complaints revealed no other complaints have been received for this production order number.Conclusion: as a result of the investigation there is no indication of a quality product 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, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8324311
• Report Number: 2648035-2019-00168
• Device Sequence Number: 14033778
• Product Code: HQL
• UDI-Device Identifier: 05050474531543
• UDI-Public: (01)05050474531543(17)210731
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2020
• 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: 07/31/2021
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 02/21/2019; 10/25/2020
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 03/14/2019; 11/09/2020
• 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