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

Model Number	AAB00
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown, information not provided.If implanted; give date: not applicable as the iol was not implanted.If explanted; give date: not applicable as the iol was not implanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported during product handling and prior to insertion of aab00 22.0 diopter intraocular lens (iol) model there was a tear in the pouch.Through follow up, customer account provided additional information confirming the primary pouch had been breached, the procedure was completed successfully using backup lens of the same model and diopter size.Patient outcome was reported as fine.There is no patient contact with the initial lens, no serious patient injury, no medical complications, and there was no surgical intervention required.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Additional information device available for evaluation: yes.Returned to manufacturer on: 11/14/2018.Device evaluated by manufacturer: yes.Device evaluation: the aab00 lens was received inside of a third-party sterilization bag with its lens case and the lens partially inserted into a 1mtec30 cartridge.The sterilization bag was received inside of an aab00 lens box labelled with sn (b)(4) which also contained a second sterilization bag with the lens, lens case, and a 1mtec30 cartridge for that lens.All contents were kept inside a clear plastic bag.The original sterile pouch packaging was not returned in the package.The reported issue could not be confirmed.Manufacturing records review: during the manufacturing record review of the production order for this serial number, no product deficiency was identified.The documentation shows that the production order was manufactured according to specifications.Historical data analysis: a search of complaints revealed no other complaints have been received for this production order number.Labeling review: the labeling review was completed and revealed that the directions for use (dfu) provide the customer with proper usage instructions and guidelines.Conclusion: as a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not confirmed as the lens was returned in a third party sterilization bag.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; 1700 e. st. andrew place; santa ana CA 92705
• MDR Report Key: 8022504
• Report Number: 3011852734-2018-00202
• Device Sequence Number: 16583274
• Product Code: HQL
• UDI-Device Identifier: 05050474548701
• UDI-Public: (01)05050474548701(17)220701
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2020
• 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: 07/01/2022
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 12/06/2018; 10/25/2020
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 12/10/2018; 11/04/2020
• 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