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

Model Number	AAB00
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that there is a potential defect, lens might have a debris on it.This was observed when removing lens from packaging.There was no patient contact.No further information provided.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 8/7/2018.Device returned to manufacturer: yes.The product was returned to the manufacturing site for evaluation.Visual inspection under 12x microscope magnification was performed by a qualified final inspection manufacturing specialist showed no dirt or particle was found.The lens is considered good and passed cosmetic inspection.The complaint cannot be confirmed.The manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other complaints have been received for this production order number.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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
• MDR Report Key: 7649116
• Report Number: 3011852734-2018-00112
• Device Sequence Number: 134616
• Product Code: HQL
• UDI-Device Identifier: 05050474548718
• UDI-Public: (01)05050474548718(17)200608
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2018
• 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: 06/08/2020
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 09/25/2018
• 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