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

Model Number AR40M

Device Problem Break (1069)

Patient Problems Hemorrhage/Bleeding (1888); Capsular Bag Tear (2639); Vitrectomy (2643)

Event Date 05/28/2019

Event Type  Injury  

Manufacturer Narrative

If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It reported after inserting an ar40m intraocular lens (iol) into the patient's operative eye, the haptic broke which resulted in a vitrectomy, and removal of the lens.Through follow up, customer account provided additional information stating a torn capsular bag occurred, vitreous prolapse, and iris bleed with blood falling into the posterior chamber (vitreous hemorrhage).It was also reported the incision was enlarged to allow lens removal, post-op vision reported as poor, suture(s) were required, and the patient left facility (b)(4).No additional information was provided to johnson & johnson surgical vision.

Manufacturer Narrative

Device available for evaluation; returned to manufacturer on: 07/01/2019.Device evaluation: a visual inspection was performed, the following were the observations: particles/fibers were in lens surface.The two (2) haptics (loops) were detached.There was a haptic detached verified, not a haptic damaged.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 since there are indications the unit was handled and explanted.A product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search revealed that no additional complaints for this order number have been received.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not 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 nr-0148919 and capa-010215.

• Brand Name: SENSAR
• 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: 8724805
• MDR Text Key: 148914563
• Report Number: 2648035-2019-00659
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474514218
• UDI-Public: (01)05050474514218(17)220605
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/12/2020

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: 06/05/2022
• Device Model Number: AR40M
• Device Catalogue Number: AR40M00015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• 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: 05/30/2019
• Initial Date FDA Received: 06/21/2019
• Supplement Dates Manufacturer Received: 07/02/2019; 10/25/2020
• Supplement Dates FDA Received: 07/30/2019; 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR