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

Model Number	AAB00
Medical Device Problem Codes	Break (1069); Failure to Eject (4010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Gender/sex: unknown, information not provided.Date of event: unknown, not provided.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was initially reported that an intraocular lens (iol) was stuck in the inserter, and the optic broke while inserting into the patient¿s left eye.Additional information was provided stating the lens had been fully inserted into the eye, and it was the haptic that broke when the lens unfolded.The lens was then cut out, and replaced with the back-up lens.Reportedly, there was no incision enlargement, sutures, or vitrectomy required.The patient was doing okay when discharged.No other information provided.
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 7/10/2019.Device returned to manufacturer ¿ yes.Device evaluation: the sample was received within the original box and daisy wheel.A visual inspection of the returned sample revealed the lens to be freely inside of the box outside of the daisy wheel.The lens was cut into two halves completely through the center of the optic body, most likely to aid in explant.Both haptics of the lens were missing, and the cartridge was not returned.Based on the condition of the return, further analysis is not possible.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related this production order (po) was performed the search revealed no other complaints have been received for this po number.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and 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: 8761116
• Report Number: 3011852734-2019-00136
• Device Sequence Number: 1541604
• Product Code: HQL
• UDI-Device Identifier: 05050474548695
• UDI-Public: (01)05050474548695(17)220531
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2020
• 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: 05/31/2022
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/05/2019
• Supplement Date Received by Manufacturer: 07/17/2019; 10/25/2020
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 08/09/2019; 11/13/2020
• 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: EMERALDC30 CARTRIDGE LOT# CD12144
• Date Report Sent to FDA: 01/01/2005