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

Model Number AR40E

Device Problem Unintended Movement (3026)

Patient Problems Intraocular Pressure Increased (1937); Blurred Vision (2137); Vitrectomy (2643)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

Explant date: if explanted, give date: not applicable, as lens remains implanted.The device is not returning for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that an ar40e intraocular lens (iol) was implanted but after 18 yrs.Of the doctor not seeing the patient, the patient presented herself to the doctor with a dislocated lens bag complex with pseudoexfoliation glaucoma in the right eye.It was noted that the lens rotated.The patient reported blurry vision and increased intraocular pressure (iop).The doctor did lens repositioning, gonio-assisted transluminal trabeculectomy, and pars plana vitrectomy of the right eye.Vision is now good and iop is down.No patient post-op injury.The lens remains implanted.No other information was provided.

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: 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: 9567098
• MDR Text Key: 177546789
• Report Number: 2648035-2020-00030
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474502062
• UDI-Public: (01)05050474502062(17)210118
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,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: 09/30/2004
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00180
• Was Device Available for Evaluation?: No
• 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: 12/16/2019
• Initial Date FDA Received: 01/08/2020
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR