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

Model Number	Z9002
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided.Best estimate of date of event is between (b)(6) 2008 and (b)(6) 2019.(b)(4).Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a model z9002 intraocular lens (iol) was implanted in 2008 has calcified.Therefore, the doctor explanted the iol.It was stated that the patient has recovered post-explant.Despite several follow-ups for additional information at the time of this report, no further information has been received.
Additional Manufacturer Narrative
Additional information: device available for evaluation; returned to manufacturer on: 7/24/2019.Device evaluation: a visual inspection was performed to the iol and the following were the observations: some particle and fibers were observed in lens surface which is an indication of handling.A half of the lens was returned, including the haptic (loop) as indication of the removal process.The haptic (loop) was observed distorted (d/l).The complaint issue inclusions was not verified.The lens was cleaned to verified, if opacification was observed; no opacity was observed.Based on the visual evaluation of the returned unit it could not be determined that the cause of the issue reported is related to the manufacturing process.The lens was implanted since 2008.A product quality deficiency could not be determined.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no additional complaints were received from this production order.Conclusion: as a result of the investigation, there is no indication of a product quality 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: 8737653
• Report Number: 2648035-2019-00666
• Device Sequence Number: 2573260
• Product Code: HQL
• UDI-Device Identifier: 05050474530737
• UDI-Public: (01)05050474530737(17)201121
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: 01/31/2013
• Device Model Number: Z9002
• Device Catalogue Number: Z900200220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/30/2019
• Supplement Date Received by Manufacturer: 08/12/2019; 10/25/2020
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 09/04/2019; 11/13/2020
• 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