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

Model Number	AAB00
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable as lens was not implanted.If explanted, give date: not applicable as lens was not explanted.Attempts have been made to obtains missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that a aab00 28.0 diopter monofocal intraocular lens started to deliver into the patients left eye but was difficult to push forward to implant.Upon delivery the lens sliced in half and one half of the iol was in the patients eye the other half in the loader.The part of the lens that was in the eye was immediately removed.A replacement lens was implanted within the same procedure without further incidence.Reportedly there was no incision enlargement and no vitrectomy.No further information was provided.
Additional Manufacturer Narrative
Corrected data: at the time of the initial report the concomitant product was known (1mtec30 cartridge) however was inadvertently not provided.The field has now been updated accordingly.Concomitant medical products: 1mtec30 cartridge, lot# unknown.Device evaluation: the product was not returned to the manufacturing site.Therefore, product testing could not be performed, and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar/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 and the reported issue could not be verified.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 AND JOHNSON SURGICAL VISION, INC; 1700 e st andrew pl.; santa ana CA 92705
• MDR Report Key: 8372578
• Report Number: 3011852734-2019-00046
• Device Sequence Number: 1098050
• Product Code: HQL
• UDI-Device Identifier: 05050474548824
• UDI-Public: (01)05050474548824(17)220228
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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: Nurse
• 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: 02/28/2022
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000280
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 03/21/2019; 10/25/2020
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 04/15/2019; 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1MTEC30 CARTRIDGE LOT# UNKNOWN
• Patient Age: 63 YR
• Date Report Sent to FDA: 01/01/2005