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	Capsular Bag Tear (2639)
Date of Event	02/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, information not provided.If implanted, if explanted, give date: not applicable, as lens was not implanted.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that when customer was about to implant the intraocular lens, the capsule started to collapse.This was observed while inserting lens into the patient's left eye.Reportedly only the tip of lens was inserted and then surgeon removed the lens in the same surgical procedure.Patient has recovered.No further information provided.
Additional Manufacturer Narrative
Device available for evaluation; returned to manufacturer on: 8/1/2019.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection using magnification was performed to the returned sample: the zcb00 lens was returned in its original package.The sample was evaluated, and the lens was observed with residues that looks like body fluids on the lens related to the handling of the unit in a surgical procedure.Loose fibers/particles were observed on lens related to the handling of the unit out of a sterile environment.Both haptic was also observed folded.The complaint issue reported was not verified and it could not be determined if the reported issue is related to manufacturing process as the reported lens was handling and used in a surgical procedure.Based on the product returned evaluation, a product quality deficiency or product malfunction could not be determined.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints related to this production order was conducted in the complaint system.The search revealed that no other complaint has been received for this production order number.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 (b)(4) and capa (b)(4).

• 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: 8853949
• Report Number: 2648035-2019-00841
• Device Sequence Number: 2399475
• Product Code: HQL
• UDI-Device Identifier: 05050474531840
• UDI-Public: (01)05050474531840(17)220620
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2020
• 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: 06/20/2022
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 08/13/2019; 10/25/2020
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 08/23/2019; 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