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

Model Number	AAB00
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.Date of event: unknown, information not provided.If implanted, give date: unknown, information not provided.If explanted, give date: unknown, information not provided.(b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that fiber on lens and was not inserted.No further information provided.
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.
Additional Manufacturer Narrative
Corrected data/additional information: through follow-up it was confirmed that there was no patient contact with the lens or the reported fiber.Therefore, this complaint no longer meets the reporting criteria for a reportable malfunction.No further information will be provided under manufacturing report number 2648035-2020-00013.Section d10: device available for evaluation ¿ yes, returned to manufacturer on 1/28/2020 section h3: device returned to manufacturer ¿ yes.Device evaluation: there was a lens inside a lens case.The lens was observed under microscope and it was observed cover with appear to be viscoelastic residues.Fiber were not observed in the optic zone.A fiber was observed in one of the haptics.The complaint was verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that one other complaint has been received for this production order number.Investigation was reviewed and is not related to this complaint since is related to iol torn.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.

• 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: 9554537
• Report Number: 2648035-2020-00013
• Device Sequence Number: 11537279
• Product Code: HQL
• UDI-Device Identifier: 05050474548688
• UDI-Public: (01)05050474548688(17)230322
• 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: company representative,foreig
• Initial Reporter Occupation: Nurse
• 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: 03/22/2023
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 02/17/2020; 10/25/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 03/14/2020; 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