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 Code Available (3191)
Date of Event	07/24/2018
Type of Reportable Event	Serious Injury
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 lens was not implanted.If explanted, give date: not applicable, as the lens was not implanted.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported when inserting zcb00 15.5 diopter intraocular lens (iol) into the eye the lens was scratched by the injector upon insertion.There was incision enlargement, no vitrectomy, and a similar lens was used to complete the procedure.Attempts were made to contact the customer account requesting additional information however, no response was received.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Additional information: device available for evaluation: yes, returned to manufacturer on: 10/15/2018, device returned to manufacturer: yes.Device evaluation: only packaging components were received.The reported issue could not be verified.A product quality 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 on complaints revealed that no additional investigations request were received for this production order number.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 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 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-(b)(4).

• 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: 7987628
• Report Number: 2648035-2018-01361
• Device Sequence Number: 16492706
• Product Code: HQL
• UDI-Device Identifier: 05050474531628
• UDI-Public: (01)05050474531628(17)210815
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 11/04/2020
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/15/2021
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000155
• 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: 11/09/2018; 10/25/2020
• Initial Report FDA Received Date: 10/19/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005