MAUDE Adverse Event Report: AMO UPPSALA AB HEALON; AID, SURGICAL, VISCOELASTIC

Model Number HEALON GV

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

Patient Problems Corneal Edema (1791); Endophthalmitis (1835); Hyphema (1911); Inflammation (1932); Intraocular Pressure Decreased (4468)

Event Type  Injury  

Manufacturer Narrative

Age/date of birth (months): ages range between 48.7-60.6 (ac group); 51.8-65.8 (pc group).Sex/gender: (male: female): 8:16 (ac group); 10:9 (pc group).Information unknown, not provided.Date of event: article acceptance date is february 15, 2021.Model number: partially known, as the lot number was not provided.A complete catalog number is unknown as the lot number was not provided.Lot number: unknown, information not provided.Expiration date: unknown, as the lot number was not provided.Udi number: a complete udi number is unknown, as the lot number was not provided.Implant date: not applicable as this is not an implantable device.Explant date: not applicable as this is not an implantable device.Device manufacture date: unknown, as the lot number was not provided.Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing record evaluation: the manufacturing record review could not be performed because the lot number of the complaint product is unknown.Since the lot number is unknown, the complaint history review could not be performed.Conclusion: since the sample of the complaint product was not returned, and lot number is unknown, it is not possible to determine a malfunction and/or product quality deficiency.Citation: huang, k.-h., chen, c.-l., lu, d.-w., chen, j.-t., chen, y.-h.(2021).Outcomes of small size ahmed glaucoma valve implantation in asian chronic angle-closure glaucoma.J.Clin.Med 10(4), 813, https://doi.Org/10.3390/jcm10040813.An attempt has been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

The following article was received based on a literature review: article: outcomes of small size ahmed glaucoma valve implantation in asian chronic angle-closure glaucoma.A retrospective study was done to report the results of small size ahmed glaucoma valve (agv) insertion in adult chronic angle-closure glaucoma (acg) patients and evaluated the benefit and safety of modified technique (sclerectomy) for agv tube insertion to anterior chamber.A total of 43 eyes of 43 patients with chronic acg underwent small size agv insertion and were divided into anterior chamber (ac) group (n=24 eyes; 12 right and 12 left) and posterior chamber (pc) group (n=19 eyes; 6 right and 13 left).Anterior chamber paracentesis was made by micro vitreoretinal (mvr) blade and about 0.1 ml viscoelastic (healon gv, advanced medical optics) injection was performed through the paracentesis.In the ac group, 7 eyes were considered as failure in which 5 underwent second agv insertions, 1 underwent evisceration of the eyeball and 1 underwent a cyclodestructive procedure.In the pc group, 7 eyes were also considered as failure in which 5 underwent second agv implantations and 2 underwent cyclodestructive procedures.In the ac group, 12 patients showed no change in vision and 8 showed a decline.In the pc group, 11 showed no change in vision and 5 showed a decline.Post-operative complications in the ac group include: (n=1 eye) hyphema, (n=1 eye) flat chamber/hypotony, (n=3 eyes) encapsulated bleb, (n=1 eye) endophthalmitis, and (n=2 eyes) bullous keratopathy.Post-operative complications in the pc group include: (n=5 eye) hyphema, (n=1 eye) flat chamber/hypotony, (n=3 eyes) encapsulated bleb, and (n=1 eye) bullous keratopathy.Further interventions were not reported.Other jnj products were mentioned but no complaints were reported against them.A copy of the article is provided with this report.

• Brand Name: HEALON
• Type of Device: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): AMO UPPSALA AB; rapsgatan 7; uppsala, uppsala län 754 5 0; SW 754 50
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 12929880
• MDR Text Key: 286762402
• Report Number: 3012236936-2021-00143
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HEALON GV
• Device Catalogue Number: 10291960
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other