MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. HEALON 5 PRO; OVDS

Model Number TV60ML

Device Problem Contamination (1120)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2020

Event Type  malfunction  

Manufacturer Narrative

If implanted; give date: not applicable, as the viscoelastic is not an implantable device.If explanted; give date: not applicable, as the viscoelastic is not an implantable device; therefore, not explanted.Phone: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was initially reported issues with healon 5 pro.Customer found white particle in 2-3 units, only one product was kept.The issue was noticed when doctor implanted the lens.No extra surgery or medication was required.Everything went fine for the patient.No further information has been provided.This report is for patient #2.A separate report is being submitted for patient #1.

Manufacturer Narrative

Section d10 - device available for evaluation? yes.Section d10 - date returned to manufacturer: 21st january 2021.Section h3 - device evaluated by manufacturer? yes.Visual inspection and the stereomicroscope inspection of the complaint sample, the customer¿s narrative, and the reported device problem code of dc-foreign material - loose, the complaint is confirmed.The material appears to be a gray coring particle which is formed when the healon cylinder is activated.Manufacturing record evaluation: a device history record (dhr) for healon 5 pro, lot# uh31240 was performed.No deviation related to the complaint is reported in the manufacturing record.A review of records related to the device including labeling, complaint trending, and risk documentation was performed.The review of the device history record (dhr) for healon 5 pro, lot# uh31240 showed that there were no issues or non-conformities.The healon gv pro met all specifications prior to being released.Based on the investigation results, no corrective action has been issued a review of the records related to healon 5 pro that included labeling, manual, and risk documentation reviews was performed.Labeling provides possible complications that can be caused by the surgical/treatment procedure being performed.The trend review shows that there is not a recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.There was no product deficiency identified.Conclusion: although, the complaint was confirmed, the presence of a gray rubber coring particle upon expelling healon solution is a known issue and is addressed in the healon pro family products¿ risk assessments.However, as there is no indication of an upward trend in the number of complaints with this type of issue.Additionally, the directions for use(dfu) has the following statement ¿express a small amount of healon5 pro ovd over from the syringe prior to use and carefully examine it during use to avoid injecting minute rubber particles which may be released when the syringe diaphragm is punctured.".Johnson & johnson surgical vision will continue to monitor this type of complaints per global complaint trending.No further investigation is required at this time.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: HEALON 5 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: 10987321
• MDR Text Key: 220961785
• Report Number: 3004750704-2020-00064
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474701632
• UDI-Public: (01)05050474701632(17)230430(10)UH31240
• 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
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: TV60ML
• Device Catalogue Number: 10290015
• Device Lot Number: UH31240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1