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

Model Number	AR40E
Medical Device Problem Codes	Break (1069); Separation Problem (4043)
Health Effect - Clinical Codes	Corneal Edema (1791); Hyphema (1911); No Code Available (3191)
Date of Event	05/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable.The intraocular lens was removed and replaced during the same procedure.If explanted, give date: not applicable.The intraocular lens was removed and replaced during the same procedure.(b)(6).(b)(4).All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that both haptics broke inside of the patient's eye after the monofocal intraocular lens (iol), model ar40e, 17.0 diopter was implanted.The lens was removed with difficulty as both haptics were detached from the optic.During the same procedure, the lens was removed, and the incision was enlarged.A second lens of the same model was implanted.It was indicated that due to the broken haptics, the patient experienced hyphema as the haptic touched the iris.Reportedly, the surgeon was obligated to leave a bit of ophthalmic viscosurgical device (ovd).On day one (d1), the patient was really hypertone at 45 and there was corneal edema which the patient was under medication diamox simbrinza ganfort.On day three, the patient was better, hyphema and corneal edema had reduced, and tonicity was normal.It was indicated that the lens is available.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation; device returned to manufacturer on: 06/06/2019.Device evaluation: according to the analysis of the product returned, the reported issue of haptic detached was verified.However, due to the conditions in which the sample was returned, it is not possible to determine that the reported issue is related to manufacturing process.A 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.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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, inc.Has been submitted.
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: 8680586
• Report Number: 2648035-2019-00624
• Device Sequence Number: 19279629
• Product Code: HQL
• UDI-Device Identifier: 05050474502048
• UDI-Public: (01)05050474502048(17)200921
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2020
• 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: 09/21/2020
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 06/17/2019; 10/25/2020
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 07/12/2019; 11/12/2020
• 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
• Date Report Sent to FDA: 01/01/2005