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

Model Number	AR40E
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluation: the intraocular lens (iol) was returned to the manufacturing site for investigation.The returned lens was received 02/28/2019.The returned ar40e lens was received inside the lens case in the original packaging.The lens was observed under microscope, 10x magnification, with a cut in the surface.Some viscoelastic residue was observed in the lens surface.A detached haptic (loop) was observed, the other haptic (loop) looked in good condition.The condition of the lens is typically related to the removal process of the lens, a product deficiency could not be determined.The complaint issue could not be confirmed.Manufacturing record review: a review of the manufacturing records was performed.Based on the manufacturing records review and related documents the production order was manufactured according specifications.A search of complaints revealed that no additional complaints have been received for this production order number.Labeling review: the directions for use (dfu) adequately provides instructions, precautions, along with warnings for the proper use and handling of the product.Based on the results of the investigation; no product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol), implanted in the left eye, was removed and replaced during the initial procedure.Customer reported loading issues with trouble delivering the lens implant.The lens became stuck in the entry wound and had to be cut out and removed.Replacement implant was successfully delivered.Wound was sutured.The case was completed without further incident.No further information was provided.
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: SENSAR
• 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: 8392979
• Report Number: 2648035-2019-00287
• Device Sequence Number: 11243134
• Product Code: HQL
• UDI-Device Identifier: 05050474502192
• UDI-Public: (01)05050474502192(17)230822
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2020
• 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: 08/22/2023
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 11/10/2020
• 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: 82 YR
• Date Report Sent to FDA: 01/01/2005