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
Date of event: unknown as information was not provided.If implanted; give date: not applicable as the iol was not implanted.If explanted; give date: not applicable as the iol was not implanted.(b)(4).Device evaluation: product testing could not be performed because the product was not returned.A product quality deficiency could not be confirmed.The reported issue 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 that one (01) additional complaint folder for this production order number has been received.These complaint issues are not related to this complaint issue reported.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported the intraocular lens (iol) haptic got caught on the capsulorrhexis and was unable to move due to loose zonules.It was indicated the lens was opened and not used thus indicating the iol was not implanted.Through follow up, customer account provided additional information confirming there was no damage to the optic surface or lens haptics after the lens was caught in the capsulorhexis.The lens did not contribute to loose zonules and there was no unplanned vitrectomy.Unplanned incision enlargement was performed and unplanned suture(s) were required.No additional information was provided.
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: 10124821
• Report Number: 2648035-2020-00434
• Device Sequence Number: 2464259
• Product Code: HQL
• UDI-Device Identifier: 05050474531772
• UDI-Public: (01)05050474531772(17)231117
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• 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
• Report Date (Section B): 10/30/2020
• 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: 11/17/2023
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000230
• 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: 05/20/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 10/30/2020
• 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