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 Consequences Or Impact To Patient (2199)
Date of Event	05/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that there was debris on lens when inserted to patient's eye.Additional information was received and it was confirmed that lens was removed and replaced in same procedure.There was no incision enlargement, no serious adverse event, no surgical or medical intervention and no patient injury.Reportedly lens with different model was used as replacement for the patient.No further information provided.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 7/31/2018.Device returned to manufacturer? yes.The product was received in opened pouches of the original packaging.Visual inspection with unaided eye shows that the lens was found in pieces.Due to the lens had patient contact, the returned sample was visually inspected by a qualified inspector in biosafety cabinet since the lens was not yet decontaminated.The inspection showed the lens was covered in dirt and there were some traces of ophthalmic viscosurgical devices (ovd) on both sides of the lens surface.The pieces were re-inspected again using a 12x magnification, shows no abnormality.The traces of ovd has been removed during the decontamination and there was no embedded dirt or debris on both pieces.Complaint event on dirt and debris is confirmed; however, the cause of the contamination was not able to be confirmed since the lens has been handled by the user.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.The search revealed 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 for the proper use and handling of the product.As a result of the investigation 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
• MDR Report Key: 7649108
• Report Number: 3011852734-2018-00111
• Device Sequence Number: 16557171
• Product Code: HQL
• UDI-Device Identifier: 05050474548701
• UDI-Public: (01)05050474548701(17)220330
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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): 09/20/2018
• 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: 03/30/2022
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• 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: 08/29/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 09/20/2018
• 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