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

Model Number CLRFLX

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Date 12/09/2019

Event Type  Injury  

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 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.

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.

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
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9613050
• MDR Text Key: 175908246
• Report Number: 2648035-2020-00068
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474501546
• UDI-Public: (01)05050474501546
• Combination Product (y/n): Y
• PMA/PMN Number: P880081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/04/2020

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
• Device Operator: 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 Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 12/27/2019
• Initial Date FDA Received: 01/21/2020
• Supplement Dates Manufacturer Received: 02/07/2020; 10/25/2020
• Supplement Dates FDA Received: 03/06/2020; 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR