MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. SENSAR; INTRAOCULAR LENS

Model Number AR40E

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); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/02/2018

Event Type  Injury  

Manufacturer Narrative

Age/date of birth (months): ages are 9.2 ± 8.5 (group i); 57 ± 27.5 (group iii).Sex/gender: (male: female): 18:12 (group i); 40:20 (group iii).Weight & ethnicity: information unknown, not provided.Date of event: exact dates not provided, article acceptance date is (b)(6) 2018.Serial number: unknown, information not provided.A complete catalog number is unknown as the serial number was not provided.Expiration date: unknown, as the serial number was not provided.Udi number: a complete udi number is unknown, as the serial number was not provided.Implant date: unknown, information not provided.Explant date: not applicable, as lens was not explanted.The device was not returned for analysis.The serial lot/serial 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 serial number was not provided.(b)(4).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 hyaluronidase 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.This report is for the reported adverse events on the intraocular lens, model ar40e.A separate report is being submitted to capture the reported issues on the healon (ovd) device.

• Brand Name: SENSAR
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; road 402 north, anasco ind. pk; anasco, PR 00610 ; 7142478552
• MDR Report Key: 11675114
• MDR Text Key: 252967634
• Report Number: 2648035-2021-07579
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• PMA/PMN Number: P980040
• 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: AR40E
• Device Catalogue Number: AR40E
• 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