MAUDE Adverse Event Report: AMO UPPSALA AB UNK-OVD_HEALON; AID, SURGICAL, VISCOELASTIC

Model Number UNKNOWN

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

Patient Problems Hyphema (1911); Intraocular Pressure Increased (1937); Intraocular Pressure Decreased (4468)

Event Type  Injury  

Event Description

The following article was received based on a literature review: article: multicenter case series of standalone xen implant vs.Combination with phacoemulsification in turkish patients a retrospective, multicenter study was done to evaluate and compare the efficacy, safety and needling timing and rates of standalone xen implant vs.Combination with phacoemulsification in turkish patients.A total of 58 eyes of 54 patients with open angle glaucoma including primary open angle glaucoma and pseudoexfoliation glaucoma underwent either standalone xen implantation (xen alone) (n=26 eyes of 24 patients) or xen implantation with combined phacoemulsification surgery (xen + phaco) (n=32 eyes of 30 patients).In the xen + phaco group, after the standard phacoemulsification procedure, the viscoelastic device (healon ophthalmic viscoelastic device; abbott medical optics) was left in place after the lens implantation and the xen implant was then inserted.In the xen + phaco group, postoperative complications include hypotonia (n=4 eyes) and hyphema (n=2).All eyes with hypotonia or hyphema were resolved spontaneously without any surgical intervention.Postoperative intraocular pressure (iop) >30mmhg spike was observed in 2 eyes on week 1 in the xen + phaco group of which has responded to short-term topical anti-glaucomatous treatment.In the xen + phaco group, 1 eye underwent trabeculectomy (at postoperative month 3) and 3 eyes required revision surgery due to implant dislocation.A failure rate of 12.5% (iop = 18, < %20 reduction with medication) was also reported in the xen + phaco group.

Manufacturer Narrative

Age/date of birth: no exact ages were provided, range between 34 and 87 years of age.Gender: 43 male and 15 female patients.Date of event: the study was conducted between december 2016 and august 2018.Model number: unknown as the lot number was not provided.Catalog number: 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: unknown, as the lot number was not provided.Implant date: n/a.Healon is not an implantable device.Explant date: n/a.Healon is not an implantable device; therefore, not explanted.Device evaluation: the product testing could not be performed because the product was not returned.The reported complaint could not be confirmed.Manufacturing record review: the manufacturing record and complaint history were not reviewed since the lot number is unknown.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.Device manufacture date: unknown, as the lot number was not provided.Citation: eraslan, m.; atakan oezcan, a.; dericioglu, v.; ciloglu, e.Multicenter case series of standalone xen implant vs.Combination with phacoemulsification in turkish patients (2021) int ophthalmol (2021) 41:3371¿3379 https://doi.Org/10.1007/s10792-021-01899-7.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: UNK-OVD_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: 15705435
• MDR Text Key: 302768574
• Report Number: 3012236936-2022-02635
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• 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: 10/06/2022
• 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): Required Intervention