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

Model Number	AR40E
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: not applicable, lens was not used.If explanted; give date: not applicable, lens was not used.Initial reporter: unknown/ not provided.(b)(6).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the optic of the intraocular lens was damaged.There was no patient involvement and/or injury reported.Based on follow up information, the lens optic was torn upon opening the package.No additional information provided.
Additional Manufacturer Narrative
The product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.The manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to specifications.A search revealed that no additional investigation request for this production order.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: SENSAR
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7410190
• Report Number: 2648035-2018-00489
• Device Sequence Number: 13710643
• Product Code: HQL
• UDI-Device Identifier: 05050474501911
• UDI-Public: (01)05050474501911(17)220505
• Combination Product (Y/N): Y
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2018
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 05/05/2022
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00090
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/12/2018
• Supplement Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 04/09/2018
• Supplement Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005