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

Model Number	AAB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implant date: not applicable, as lens was removed/replaced in the initial surgery.Explant date: not applicable, as lens was removed/replaced in the initial surgery.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an aab00 intraocular lens (iol) was implanted and immediately removed due to a defect in the lens.The iol was replaced with a similar lens of the same power.Additional information revealed the initial lens, implanted into the patients right eye, one of the filaments broke (haptic).The lens was removed and was replaced with the same kind, same power of iol.There were no patient injuries and no additional intervention was reported.The patient was doing great post-operatively.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 2/26/2019.Device returned to manufacturer: yes.Device evaluation: the returned sample was received on february 26, 2019.Visual inspection at microscope magnification was performed.Lubricant residues and loose particles were observed on the lens surface.Also, some depression marks can be observed on lens that could be related to removal process.One of the lens's haptics was broken, but the other looks in good conditions.The reported issue was verified.However, due to the condition in which the lens was received it is not possible to determine that the reported issue is related to the manufacturing process or to the surgical process.Product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search revealed no other complaints have been received for this production order number.Labeling review: 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.All pertinent information available to johnson & 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 nr-0148919 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: 8329774
• Report Number: 3011852734-2019-00037
• Device Sequence Number: 16632884
• Product Code: HQL
• UDI-Device Identifier: 05050474548497
• UDI-Public: (01)05050474548497(17)220130
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/30/2022
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 03/08/2019; 10/25/2020
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 04/04/2019; 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Date Report Sent to FDA: 01/01/2005