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

Model Number	ZCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted; if explanted; give date: not applicable as lens was removed/replaced within the initial procedure.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the haptic broke in patient's eye during insertion and was removed during same procedure.The incision was enlarged.Another lens, same model and diopter was used for the replacement.Patient reported as fine post op.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: product evaluation was not performed because the product has been discarded.The complaint issue reported could not be verified and no product deficiency could be identified manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that no other complaints have been received for this production order.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.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 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: 9407618
• Report Number: 2648035-2019-01274
• Device Sequence Number: 11221210
• Product Code: HQL
• UDI-Device Identifier: 05050474531598
• UDI-Public: (01)05050474531598(17)230712
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2020
• 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: 07/12/2023
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000140
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 12/13/2019; 10/25/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 01/07/2020; 11/05/2020
• 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