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

Model Number TG85ML

Device Problems Difficult to Remove (1528); Obstruction of Flow (2423)

Patient Problems Eye Burn (2523); No Code Available (3191)

Event Date 12/05/2019

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.Gender/sex: unknown, information 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; therefore, not explanted.Last name: unknown, information not provided.Phone: (b)(6).(b)(4).This complaint is part of the recall - report number 2020664-12/02/19-001-r: johnson & johnson surgical vision (jjsv) issued a voluntary recall on november 22, 2019.It has been reported customers have described healon gv pro as behaving differently than the legacy healon gv, especially in regard to the techniques required to remove the product from the eye.An increase of intra-ocular pressure (iop) is reported if there are small amounts of healon gv pro remaining behind the operative eye.This voluntary recall is being initiated due to received reports of healon gv pro being difficult to remove from the eye, leading to increased post-operative iop requiring additional intervention.Potential clogging of phacoemulsification equipment tubing has also been reported, which may lead to delay in the procedure or ocular injury.There are twenty-one affected lot numbers.The recall notification letter has been sent to all customers instructing them to return the units of healon gv pro from the twenty-one (21) affected lots.Johnson & johnson surgical vision has initiated a corrective and preventative actions (capa) to investigate and address the issue.Action items generated from the capa will be submitted in the future interim report(s) as part of the recall process.Device evaluation: since no sample was returned for investigation product evaluation is not performed and a product deficiency is not confirmed.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that two similar complaints has 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 and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that during the injection of the healon gv pro, the surgeon noted the product was difficult to expel and that it clogged the hand piece.The surgeon reported of acute and chronic post operation hypertonia leading to abnormalities, postop refraction corneal burn, deformed pupil, intraocular pressure increases, lens dislocation, swelling of the capsular bag leading to post refraction anomalies, blindness in a case of glaucoma patient and hypertonia requiring an early yttrium-aluminum garnet (yag) treatments.Reportedly, about one hundred (100) patients are affected.Symptoms were treated.No additional information was provided.This report captures the event for clogging of the handpieces resulting in corneal burn only for one case that occurs before the sculpting where doctor used bi-manual technique, an alcon hp with a kellman tip.Only one vial of healon gv pro was used and the cassette was not reused.This occlusion resulted on a corneal burn.Sutures done to patch up the leak.There was 0.75 of induced astigmatism, no visual impact on the patient vision.Additionally, the customer provided two different lot numbers.Due the limited information available to date, it was not possible to obtain the batch number related to this specific case.This report will pertains to the healon gv pro, lot number ue31098.A separate report will be submitted on the lot number ue31283.

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 GV 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: 9901478
• MDR Text Key: 185636815
• Report Number: 3004750704-2020-00027
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474651593
• UDI-Public: (01)05050474651593(17)220228(10)UE31098
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: TG85ML
• Device Catalogue Number: 10270514
• Device Lot Number: UE31098
• Was Device Available for Evaluation?: No
• 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: 03/03/2020
• Initial Date FDA Received: 03/30/2020
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2020664-12/02/19-001-R
• Patient Sequence Number: 1
• Treatment: ALCON HANDPIECE, KELMAN TIP; ALCON HANDPIECE, KELMAN TIP
• Patient Outcome(s): Required Intervention