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

Model Number	CLRFLX
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is unknown/ not provided.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a model clrflx 19.5 diopter intraocular lens (iol) dislocated post-operatively in the patient¿s right eye.The iol was explanted and replaced with a non-johnson and johnson iol.The patient¿s outcome was reported that there were no problems.No further information was provided.
Additional Manufacturer Narrative
Additional information: device available for evaluation; returned to manufacturer on 01/29/2020.Device evaluation: the product was returned to the manufacturing site for evaluation.A bag with a lens inside was received.The lens was observed under a microscope and it was observed with a cut, with missing parts and with a haptic detached.This condition is typically of a removed or explanted lens.Due the condition of the lens received the complaint could not be verified.A product quality deficiency was not verified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no other complaints has been received for 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-010215.

• Brand Name: CLARIFLEX
• 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: 9613050
• Report Number: 2648035-2020-00068
• Device Sequence Number: 585451
• Product Code: HQL
• UDI-Device Identifier: 05050474501546
• UDI-Public: (01)05050474501546
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2020
• 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: 09/30/2011
• Device Model Number: CLRFLX
• Device Catalogue Number: CLRFLXC195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/27/2019
• Supplement Date Received by Manufacturer: 02/07/2020; 10/25/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 03/06/2020; 11/04/2020
• 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
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005