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

Model Number AR40E

Device Problem Unintended Movement (3026)

Patient Problems Vitrectomy (2643); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluation: product testing could not be performed because the product was not returned as it was discarded.The reported complaint was not confirmed.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.The search revealed that no other complaint folder has been created for this production order number.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision has been submitted.

Event Description

It was reported that monofocal intraocular lens (model ar40e +21.5 diopter) was explanted from patient¿s operative eye in secondary surgical procedure because of patient experiencing dislocation of the lens.On (b)(6) 2019 the lens was reportedly repositioned.Pars plana vitrectomy was performed during explant procedure.In addition, intrascleral fixation and iris repair was performed.Lens from another manufacturer was used as the replacement lens for the patient.No incision enlargement and no patient injury reported.Patient is happy with the vision.No further information provided.

Manufacturer Narrative

Correction data: after submission of the initial report, it was realized that (b)(4) reposition rotationally was inadvertently reported.It should be just repositioned.All pertinent information available to johnson and johnson surgical vision has been submitted.

Manufacturer Narrative

This correction mdr is being submitted to address inaccurate information 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: SENSAR
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• Manufacturer (Section G): JOHNSON & JOHNSON SURGICAL VISION, INC.; road 402 north, km 4.2; anasco industrial park; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478200
• MDR Report Key: 9886100
• MDR Text Key: 187045080
• Report Number: 2648035-2020-00290
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474502130
• UDI-Public: (01)05050474502130(17)240816
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,10/30/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2005
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 02/27/2020
• Initial Date FDA Received: 03/26/2020
• Supplement Dates Manufacturer Received: 03/30/2020; 10/25/2020
• Supplement Dates FDA Received: 04/23/2020; 10/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2002
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention