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

Model Number	ZCB00
Medical Device Problem Codes	Break (1069); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.(b)(6).(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that doctor implanted a zcb00 intraocular lens (iol) in the capsular bag of the patient's eye.It was later found that there was a crack in optic zone of the lens.This was confirmed to not have come from the forceps.The lens was removed from the eye with an incision enlargement to 3.0mm from the original incision size of 2.75mm.There was no secondary surgical or medical intervention required.No further information provided.
Additional Manufacturer Narrative
Additional information: additional information provided indicated that the surgeon also observed white spot on the lens; however, this information was not initially provided when the crack in the optics was reported.The following field has been updated accordingly: (b)(4).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device available for evaluation; returned to manufacturer on: 07/30/2019.Device evaluation: the product was received in the original folding carton for evaluation.The lens is cut, most probably related to the removal of the lens from the patient¿s eye.Multiple damages are observed on the lens pieces; the reported issue was verified.Since the lens was handled at the surgical stage, prepared and inserted, the issue could not be determined to be related to the manufacturing process.Manufacturing record review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specifications.A search in the complaint system revealed that no additional investigation request associated to this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.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: 8642529
• Report Number: 2648035-2019-00602
• Device Sequence Number: 16598236
• Product Code: HQL
• UDI-Device Identifier: 05050474531659
• UDI-Public: (01)05050474531659(17)220626
• Combination Product (Y/N): Y
• Initial Reporter Country: TW
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/12/2020
• 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: 06/26/2022
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 08/26/2019; 08/26/2019; 10/25/2020
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 08/28/2019; 08/28/2019; 11/12/2020
• 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