MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. HEALON; OVDS

Model Number HEALON 0.85

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.Date of event: unknown, not provided, but the best estimate date is during 2018.If implanted, give date: not applicable as this is not an implantable device.If explanted, give date: not applicable as this is not an implantable device.International phone: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a black fibrous material come out in the patient's operative eye just before the continuous-tear curvilinear capsulorrhexis (ccc).Reportedly, the foreign material was removed with the tweezers during the same procedure.No treatment was required and the patient was reported having no issue.No additional information provided.

Manufacturer Narrative

Visual inspection on retained products on lot uc32057 was performed (b)(6) 2018.No visible defects were found in the package or solution; the solution was clear and colorless.All components were without defects and no visible defects on the product box.The printing on the carton and labels are correct.Product deficiency was not found on retain samples.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Device available for evaluation? yes.Returned to manufacturer on: 06/01/2018.Device returned to manufacturer? yes.Device evaluation: the returned sample consisted of an activated syringe (containing approximately 0.1ml of expellable solution), the plunger rod (screwed into the backside of the plunger) and the customer¿s cannula with protection sheath.The assembled syringe was placed into the product box along with a small glass vial.The vial contained the recovered fiber.The dark fiber recovered by the customer was visually and spectrally similar to one of the dark fibers observed on the outside of the hub of the customer¿s cannula.Dark cellulose material is not used in the production materials, worker clothing, worker¿s protection gear or cleaning materials used at the production site.Healon products are filtered through a 5m filter immediately prior to filling the glass cylinders and the fiber recovered by the customer was 10840m x 20m.This contamination found suggests it came from a source other that the healon product.Therefore, no probable cause for the observation has been determined by this investigation.Manufacturing record review: manufacturing record review of the production order and related document revealed that the product was manufactured and released according to specification.There was no discrepancy found during the review.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: HEALON
• Type of Device: OVDS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7595354
• MDR Text Key: 110859810
• Report Number: 3004750704-2018-00039
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 04987617160517
• UDI-Public: (01)04987617160517(17)201130(10)UC32057
• Combination Product (y/n): Y
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2020
• Device Model Number: HEALON 0.85
• Device Catalogue Number: 10294751
• Device Lot Number: UC32057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 08/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LENS, MODEL AND SERIAL NUMBER UNKNOWN; LENS, MODEL AND SERIAL NUMBER UNKNOWN