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

Model Number	Z9002
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	Vitrectomy (2643); No Code Available (3191)
Date of Event	12/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown/ not provided.If implanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.If explanted; give date: n/a (not applicable).The intraocular lens was removed and replaced during the same procedure.(b)(4).Attempts have been made to obtain additional information; however, to date a response has not been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a z9002 21.0 diopter intraocular lens (iol) was torn upon insertion into the patient's left eye, and had to be removed.Incision was enlarged and vitrectomy was required.No further information provided.
Additional Manufacturer Narrative
Device evaluation: the product was 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.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.Historical data analysis: a search of complaints revealed no other complaint has 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 & 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 CL
• 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: 8502014
• Report Number: 2648035-2019-00443
• Device Sequence Number: 16833931
• Product Code: HQL
• UDI-Device Identifier: 05050474530713
• UDI-Public: (01)05050474530713(17)220217
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• 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): 11/10/2020
• 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: 02/17/2022
• Device Model Number: Z9002
• Device Catalogue Number: Z900200210
• 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: 03/15/2019
• Supplement Date Received by Manufacturer: 05/16/2019; 10/25/2020
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 05/16/2019; 11/11/2020
• 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