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

Model Number	AAB00
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Codes	Visual Impairment (2138); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.Date of event: unknown, not provided, but the best estimate date is between 12/03/2018 and 01/22/2019.(b)(4).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 an aab00 20.5 diopter intraocular lens was implanted in the patient's operative eye on (b)(6) 2018.It was later explanted on (b)(6) 2019 due to fiber being found on the lens.There was no incision enlargement, no vitrectomy, and no sutures used.Reportedly, the patient is doing good.No additional information was provided.
Additional Manufacturer Narrative
Correction: a correction is required to report that the patient's visual acuity was impaired.This information was known at the time of the supplemental mdr, but inadvertently not included.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 02/06/2019.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.A visual inspection of the returned lens showed it was returned loose inside the bag and was cut in half, most probably to aid in explant.No debris or particles could be seen on the lens.Further inspection under magnification shows scratches across all surfaces of the lens but no particles or debris.The complaint event could not be confirmed.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.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
Corrected data: in review it was noted that the following information were not captured in the initial or supplemental mdr reports; therefore, they have been included in this supplemental report.Age/date of birth: (b)(6) 1940.Gender/sex: male.The affected eye was the left eye (os).(dr.B)(6).Health professional: yes.Occupation: physician.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 (b)(4) and capa-010215.

• Brand Name: SENSAR
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 8352865
• Report Number: 3011852734-2019-00041
• Device Sequence Number: 2287541
• Product Code: HQL
• UDI-Device Identifier: 05050474548671
• UDI-Public: (01)05050474548671(17)220703
• 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
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/03/2022
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 03/22/2019; 03/22/2019; 04/05/2019; 10/25/2020
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 03/22/2019; 03/25/2019; 04/09/2019; 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 WITH UNKNOWN LOT NUMBER; 1MTEC30 CARTRIDGE WITH UNKNOWN LOT NUMBER
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005