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

Model Number TG85ML

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Edema (1791); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.Date of event: unknown, not provided.Expiration date: unknown, as the lot number was not provided.Lot number: unknown, information not provided.Udi #: a complete udi # is unknown as product lot number was 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.Initial reporter phone #: (b)(6).Device manufacture date: unknown as product lot number was not provided.(b)(4).Device evaluation: the product testing could not be performed as the product was not returned for evaluation.The reported complaint cannot be confirmed.Manufacturing record evaluation: manufacturing record review cannot be performed since the lot number is unknown.A search of complaints related to lot number cannot be performed since the lot number is unknown.Conclusion: no sample was returned, and lot number is unknown, an investigation could not be performed, and no malfunction is confirmed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that on (b)(6) 2019 the patient underwent cataract surgeries using a phacoemulsification technique plus intraocular lens implants in which the product healon gv pro was used.It was indication that after interventions and as a consequence of using the defective product, patient has lost four points of visual acuity in the right eye (6/10 vs.10/10).The doctor explained to the patient about the cataract surgery and types of lenses which the patient chose a trifocal lens.Right eye 25 - left eye 26 lasik operated hypermetrope eye, matches the calculation with haiggis suite and hoffer q.Treatments: (b)(6) 2019: phaco in right eye without complications and intraocular lens in sac.(b)(6) 2019: well, light edema of cornea, rest well.Standard treatment.(b)(6) 2019: phaco in left eye, no problems.Exocin dexa tavanic and edemox nevanac x2 treatment.(b)(6) 2019: molina: near eyesight goes very well, from far eyesight 4/10 does not improve with refraction.The right eye lens is a little forward than the left eye.Oct (optical coherence tomography) normal.(b)(6) 2019: av 8/10 in ao (both eyes) / close n=1.(b)(6) 2019: av con · 2 = -125a 145 10/10 and left eye -250 to 122 10/10 // oct normal.Repositioned right eye.(b)(6) 2019: molina: now it is ok.It does not hurt, eyesight 6/10 and 10/10.Dexa in descent.No additional information was provided.

Manufacturer Narrative

Additional information: upon further follow-up it was confirmed that the lot number is ue31204.Section below then has been updated.Section d4: lot #: ue31204 manufacturing record evaluation: the manufacturing records for the healon gv pro lot number ue31204 were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.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.

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 (b)(4) and (b)(4).

• 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: 10446392
• MDR Text Key: 204344099
• Report Number: 3004750704-2020-00043
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Public: (01)(10)UNKNOWN
• 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: 01/01/2005,11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TG85ML
• Device Catalogue Number: TG85ML
• Device Lot Number: UE31204
• 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
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INTRAOCULAR LENS, MODEL/SN: UNKNOWN
• Patient Outcome(s): Required Intervention