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

Model Number TH40ML

Device Problem Contamination (1120)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2019

Event Type  malfunction  

Manufacturer Narrative

If implanted; give date: n/a (not applicable).The healon pro is not an implantable device.If explanted; give date: n/a (not applicable).The healon pro is not an implantable device; therefore, not explanted.(b)(6).

Event Description

It was reported that something like fiber came out in the patient's eye when pushed to the end.The surgeon tried to remove the fiber from the eye but it was not solid, could not be removed.There was no patient injury reported.No additional information was provided.

Manufacturer Narrative

Additional information: the following field was updated based on the additional information that was received: initial reporter name: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Section d10.Device available for evaluation? yes; returned to manufacturer on: 9/3/2019.Section h3.Device returned to manufacturer? yes.Device evaluation: the sample was received at the manufacturing site for evaluation.The complaint sample consisted of the empty glass cylinder, the cylinder holder, the plunger rod which was attached to the backside of the gray rubber plunger, and the customer¿s cannula which was attached on the front end of the holder.The syringe was assembled and placed into a plastic bag along with a dvd, showing a video of the operation.The visual inspection of the complaint sample did not indicate any material finds or similar which would confirm the customer¿s report of particles/debris.However, based upon the probable-cause summary, the customer¿s observation may be non-cured silicone oil from the surface of the rubber plunger.This is a known observation which can lead to ¿veils/cloudiness/particles¿ in the solution.However, as the returned product did not indicate this, the customer¿s report is not confirmed.As the visual inspection of the complaint sample did not indicate any material finds or similar which would confirm the customer¿s report of particles/debris, then there is no indication of a product or component defect or non-conformity.However, based upon the inspection of the complaint sample, glass and cured silicone particles can be ruled out as the material finds reported by the user.The gray rubber plunger is coated with a thin layer of silicone oil which allows for ease-of-use when advancing the plunger in the glass cylinder during use of the product.The oil is not cured onto the rubber and therefore, fiber-like wisps of silicone oil may occasionally be observed in the ovd solutions in the volume just above surface of the gray rubber plunger.This is a known observation.Based upon the description of the observed material finds and the customer narrative, the probable cause of the ¿fiber-like¿ material observed by the customer during the use of the healon product is indicated to be silicone oil from the product¿s rubber plunger.As the visual inspection of the complaint sample did not indicate any material finds or similar which would confirm the customer¿s report of particles/debris, then there is no indication of a product or component defect or non-conformity.A malfunction is not confirmed.Manufacturing records review: a manufacturing record review for the device was performed and no deviation related to current complaint is reported in the manufacturing record.A search of complaints related to lot number was performed in the complaint system and revealed that no complaints have previously been reported on this batch.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.H3 other text : placeholder.

Manufacturer Narrative

This correction mdr is being submitted to address inaccurate information 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 (b)(4).

• Brand Name: HEALON PRO
• Type of Device: OVDS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8931295
• MDR Text Key: 155551253
• Report Number: 3004750704-2019-00020
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 04987617203443
• UDI-Public: (01)04987617203443(17)211231(10)UE30912
• 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,Followup
• Report Date: 01/01/2005,11/10/2020

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: 12/31/2021
• Device Model Number: TH40ML
• Device Catalogue Number: 10260010
• Device Lot Number: UE30912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• 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: 08/01/2019
• Initial Date FDA Received: 08/26/2019
• Supplement Dates Manufacturer Received: 08/25/2019; 01/10/2020; 10/25/2020
• Supplement Dates FDA Received: 08/28/2019; 02/05/2020; 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1