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

Model Number HEALON 0.85

Device Problem Contamination (1120)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

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; therefore, not explanted.(b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

Customer reported observing that a red fiber came out the of the healon cannula after it was injected into the eye prior to hydrodissection and into the anterior chamber.The surgeon managed to remove it and there was no harm to the patient.The customer stated that it looks like a worm in the eye.No additional information provided.

Manufacturer Narrative

The returned complaint sample consisted of the healon pro cylinder with approximately 0.25 ml of remaining expellable solution and the plunger rod attached at the backside of the gray rubber stopper.The ¿red fiber¿ was placed onto a triangular surgical sponge which had been placed into a plastic jar with a screw cap.A film sequence which accompanied the complaint sample clearly indicated that a red fiber was expelled from the cannula into the eye during the surgery.Based upon the visual inspection and the ftir identification of the material, the red fiber was determined to be cellulose (cotton).It is probable that the fiber was found either in the hub of the cannula from the supplier or was introduced during the attachment of the cannula at the end-user.The cannula supplied with healon pro products is sealed at the supplier and is sterilized and ready for use.There is no exposure of the cannula to the production environment at jjsv, uppsala and therefore, if a red cellulose fiber originates from the cannula, then it is due to an issue at the cannula supplier.Additionally, there is no red cellulose used in the production facilities at jjsv, uppsala.All workers¿ cleanroom clothing used in the production areas is made from polyester; green or blue.All worker protection clothing and cleaning equipment used in jjsv, uppsala¿s production areas are made from polyester or similar.In the production areas grades a, b or c, there is no exposure to cellulose-based materials.Finally, there has not been an indication of an end-user-error (contamination of syringe with fibers) based upon this investigation.However, as the cylinder holder and cannula were not returned for inspection, then no further conclusion can be made.Visual inspection on retained products on healon pro, lot# ud31695 was performed april 03, 2019 and no visible defects were found on the package, cannula or solution.All components were included in the product, without defects.There are no visible defects on the product box and the printing on the carton and labels are correct.Product deficiency was not found on retain samples.The manufacturing records for the device were reviewed.The product was manufactured and released according to specification.A search in the complaint history revealed that no complaints have previously been reported on this batch.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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.

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.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8389122
• MDR Text Key: 137854876
• Report Number: 3004750704-2019-00002
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474609815
• UDI-Public: (01)05050474609815(17)210831(10)UD31695
• 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: 01/01/2005,11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: HEALON 0.85
• Device Catalogue Number: 10281012
• Device Lot Number: UD31695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• 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