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

Model Number	ZCB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zcb00 intraocular lens (iol) was explanted from the patient's eye.Reason for explant is unknown/not provided.No further information was provided.
Additional Manufacturer Narrative
Correction data: based on the investigation findings, an unopened inner pouch received was opened to confirm the zcb00 iol was in the lens case.The was in good condition and was not used.Therefore, the initially reported explant did not occur with this lens.This event no longer meets the reporting criteria.No further information will be provided under this report number 2648035-2019-01332.Device available for evaluation; returned to manufacturer on: 1/29/2020.Device evaluation: the product was returned to the manufacturing site.The unopened pouch was opened to confirm the iol zcb00 was in lens case.The lens was in good conditions and was not used.Based in the information provided and conditions of the returned material received, the complaint cannot be confirmed.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
Device evaluation: the product was not returned to the manufacturing site; therefore, 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.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 and 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 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: 9468443
• Report Number: 2648035-2019-01332
• Device Sequence Number: 1834512
• Product Code: HQL
• UDI-Device Identifier: 05050474534612
• UDI-Public: (01)05050474534612(17)201013
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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,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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/13/2020
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 12/23/2019; 02/03/2020; 10/25/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 12/27/2019; 03/04/2020; 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