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

Model Number AAB00

Device Problem Contamination (1120)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/25/2020

Event Type  malfunction  

Manufacturer Narrative

If implanted, if explanted, give date: not applicable as the lens was inserted, removed and replaced.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that an intraocular lens (iol) was removed from the patient¿s eye because the doctor noticed a defect in or on the lens.It was learned that the complaint was described as debris/spot on lens.The iol was then removed and replaced.No incision enlargement, no vitrectomy, no sutures.No other information was provided.

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 (b)(4).

Manufacturer Narrative

Additional information: device available for evaluation? yes.Returned to manufacturer on: 7/23/2020.Device returned to manufacturer? yes.Device evaluation: the complaint lens was received in its original lens case.Additionally, the original folding carton, patient stickers, implant notification card, and handwritten notes were received as well.Visual inspection under magnification revealed what appeared to be viscoelastic residue on the optic body and haptics and that the lens was received almost cut in half (not completely separated), which is consistent with a lens that was handled during removal and replacement.The lens was sent for further analysis of what appeared to be viscoelastic residue on the optic body, which may have been the "debris/spot on lens" as described by the customer.Fourier infrared spectroscopy (ftir) analysis indicates that the foreign materials are consistent with sodium hyaluronate, which is consistent with the viscoelastic residue of amo healon.The complaint issue could not be confirmed and therefore no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no other complaints were received from this production order.Conclusion: 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.

• Brand Name: SENSAR
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10317131
• MDR Text Key: 201730812
• Report Number: 2648035-2020-00543
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474548626
• UDI-Public: (01)05050474548626(17)240316
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,10/29/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2024
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 06/25/2020
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: 09/03/2020; 10/25/2020
• Supplement Dates FDA Received: 09/23/2020; 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR