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 Consequences Or Impact To Patient (2199)
Date of Event	04/22/2019
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 implanted.Attempts have been made to obtain 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 there was residue on intraocular lens.There was patient contact and no patient injury.Additional information was received, and it was learnt that lens was not inserted, removed and replaced.No incision enlargement, no sutures, no vitrectomy was required.Patient was doing good.No further information provided.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 5/6/2019.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.The product was received in a plastic sample vial along with its original box both kept inside a resealable plastic biohazard specimen bag.A visual inspection of the lens shows it was cut into three pieces.Traces of ovd or bss were visible on the lens surfaces.The condition of the lens is consistent with a lens that has been handled, cut, and removed.The complaint event could not be confirmed.Returned sample evaluation performed.The product was forwarded to an external lab for additional material analysis of the observed residue.Results received indicate the ftir spectrum shows the residue is consistent with inorganic salts similar to sodium hyaluronate.Manufacturing record review: he manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.The search revealed that no other complaints have been received for this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.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, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8625180
• Report Number: 3011852734-2019-00109
• Device Sequence Number: 11327809
• Product Code: HQL
• UDI-Device Identifier: 05050474548725
• UDI-Public: (01)05050474548725(17)201012
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2020
• 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: 10/12/2020
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/22/2019
• Supplement Date Received by Manufacturer: 08/05/2019; 10/25/2020
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 08/28/2019; 11/12/2020
• 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