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

Model Number	TG85ML
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); No Code Available (3191)
Date of Event	09/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable as this is not an implantable device.If explanted, give date: not applicable as this is not an explantable device.(b)(4).Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint could not be verified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no similar complaints were received for this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the healon gv pro was used in the patient¿s operative eye.During iol insertion, doctor found that the ovd was difficult to remove/difficult to use.The patient experienced intraocular pressure (iop).During the same procedure, surgical intervention was required as the doctor cut an incision to release aqueous and gv.Medications were prescribed.The patient was seen the next morning.Their iop was normal.The customer explained via follow-up, regarding this patient, she was prescribed moxifloxacin intraoperatively.After decompressing the anterior chamber the patient was given diamox and combigan.Then patient was started on moxifloxacin and prednisolone every two hours until bedtime.The following day the moxifloxacin and prednisolone were changed to 4 times a day.Her iop was 14 the following morning.Initially, it was also reported that some of his patients experienced iop postoperative.A separate file # (b)(4), was opened to capture the rest of the patients.Mdr# ? no more information was provided.
Additional Manufacturer Narrative
Brand name: was initially reported as healon, however the correct brand name is healon gv pro.Model #: was initially reported as healon gv, however the correct model number is tg85ml.
Additional 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
• Common Device Name: OVDS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9231320
• Report Number: 3004750704-2019-00045
• Device Sequence Number: 10865485
• Product Code: LZP
• UDI-Device Identifier: 05050474651654
• UDI-Public: (01)05050474651654(17)220430(10)UE31214
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P810031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2020
• Report Date (Section F): 01/01/2005

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: TG85ML
• Device Catalogue Number: 10240014
• Device Lot Number: UE31214
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 11/18/2019; 10/25/2020
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 11/20/2019; 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Date Report Sent to FDA: 01/01/2005