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

Model Number HEALON GV

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 08/06/2018

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown/ not provided.Sex/gender: unknown/ not provided.If implanted; give date: n/a (not applicable).Healon is not an implantable device.If explanted; give date: n/a (not applicable).Healon is not an implantable device.Phone number; (b)(6).The device is not returning for evaluation as it is discarded; therefore, a failure analysis of the complaint device cannot be completed.A review of the lot history record, labeling, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that particles were found in the patient's eye post-cataract surgery.The account commented that no conclusions can be drawn at this point, but the product involved was the viscoelastic healon gv.Reportedly, the sample was discarded by the customer.No further information was provided.The same issue was reported for two patient, therefore two mdrs will be filed.This is the first of two.

Manufacturer Narrative

The healon gv syringe was not returned for inspection as it was discarded by the customer.However the cannula and 1 milliliter terumo plastic syringe, containing a colorless liquid (approx.0.2-0.4 ml) was returned for inspection.The liquid in the plastic syringe was inspected.There were no particles (no glass, hardened-silicone, blue rubber particles, materials associated with the primary packaging), fibers of any types or colors, air bubbles or other similar material finds in the colorless solution.Moreover, the customer's cannula was inspected.The inner surface of the cannula hub was free from fibers/particles and there was no foreign material on the outer surface of the cannula needle.Therefore, the customer¿s reported complaint was not verified.Visual inspection on retained products of healon gv lot# uc31132 was performed.35 samples were investigated.No visible defects were found on the package, cannula or solution.The solution was clear and colorless.All components were included in the product, without defects.The cannula was without damage.No visible defects on the product box.The printing on the carton and labels are correct.Product deficiency was not found on the retain samples.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

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: HEALON
• Type of Device: OVDS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7841232
• MDR Text Key: 119039350
• Report Number: 3004750704-2018-00049
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 25050474529759
• UDI-Public: (01)25050474529759(17)201231(10)UD31132
• Combination Product (y/n): Y
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: HEALON GV
• Device Catalogue Number: 10203014
• Device Lot Number: UD31132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1