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

Model Number UNKNOWN

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

Patient Problems Corneal Edema (1791); Glaucoma (1875); Hemorrhage/Bleeding (1888); Hyphema (1911); Inflammation (1932); Intraocular Pressure Increased (1937); Retinal Detachment (2047); Vitreous Hemorrhage (2143); Capsular Bag Tear (2639)

Event Date 12/02/2018

Event Type  Injury  

Manufacturer Narrative

Age/date of birth (months): ages are (b)(6).Sex/gender: (b)(6).Exact dates not provided, article acceptance date is (b)(6) 2018.Lot unknown, information not provided.A complete catalog number is unknown as the lot number was not provided.Unk-ovd_healon pro was used as it is unknown which one of the healon pro devices were used.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.If implanted, give date: not applicable, the healon pro/ovd is not an implanted product.If explanted, give date: not applicable, the healon pro/ovd is not an implanted product.Telephone number: (b)(6).The device was not returned for analysis.The lot number for this device is not available; therefore, no further investigation can be performed.If there is any further relevant information received, a supplemental medwatch will be filed.Device manufacture date: unknown, as the lot number was not provided.Citation: balekudaru, s., agarkar, s., guha, s., charudatta mayee, r., viswanathan, n., pandey, a., singh, m., lingam, v., george, r., (2019).Prospective analysis of the predictors of glaucoma following surgery for congenital and infantile cataract.The royal college of ophthalmologists, 33(5): pp.796¿803 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: title: prospective analysis of the predictors of glaucoma following surgery for congenital and infantile cataract a prospective non-randomized, interventional, longitudinal cohort study was done to assess the incidence of and risk factors for the development of glaucoma following surgery for congenital/infantile cataract.A total of 101 eyes of 101 children with =12 years of age were divided into three groups: group i (n=30 eyes) included those who underwent surgery using an anterior approach, group ii (n=11 eyes) included those who underwent surgery using a posterior approach, and group iii (n=60 eyes) included those who underwent surgery using an anterior approach along with foldable intraocular lens implantation.In group i, an oculo viscosurgical device (ovd) using sodium hyaluronidate 7000 or sodium hyaluronate 5000 (abbott medical optics ltd) was used during anterior capsulorhexis.In group iii, foldable intraocular lenses (iols) were inserted into the capsular bag either acrylic single piece hydrophobic lenses, acrysof (alcon), or a 3 piece acrylic hydrophobic lenses sensar, model ar40e (abbot medical optics inc.) under ovd cover.Two eyes in group i (n=2) developed glaucoma as defined.Glaucoma suspects were seen in three eyes in group i (n=3) and one in group iii (n=1).Treatment for elevated intraocular pressure (iop) was required in 2 eyes with glaucoma and 5 eyes of glaucoma suspects.One child with glaucoma in unspecified group required external trabeculotomy + trabeculectomy with adjunctive mitomycin c 5 months following cataract surgery, which was followed by ahmed glaucoma valve implantation when iop remained uncontrolled, 31 months later.Intraoperative complications include extension of anterior capsulorhexis (n=1 group 1 and n=5 group iii), vitreous hemorrhage (n=1 group iii), and buttonhole formation in scleral flap (n=1 group iii).Post-operative complications include inflammation (n=1 group i), retinal detachment (n=1 group 1 and n=3 group iii), retinal hemorrhages (n=1 group 1 and n=1 group iii), hyphema (n=1 group 1 and n=1 group iii), and corneal edema + inflammation (n=1 group iii).Surgical treatment was performed for retinal detachment in 3 children.Additionally, two eyes in group iii developed posterior capsular opacification (n=2) which required yag laser capsulotomy.A copy of the article is provided with this report.This report is for the reported adverse events on the healon (ovd) device.It is unknown which specific healon pro/ovd product was used.A separate report is being submitted to capture the reported issues on the intraocular lens, model ar40e.

• Brand Name: UNK_OVD_HEALON PRO
• 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 ; rapsgatan 7; uppsala, uppsala län 754 5-0 ; SW 754 50
• MDR Report Key: 11675174
• MDR Text Key: 261742862
• Report Number: 3004750704-2021-07025
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): N
• PMA/PMN Number: P810031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• 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: UNK-OVD_HEALON PRO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2021
• 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): Required Intervention