MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. UNK_SENSAR; MONOFOCAL IOL

Model Number AR40E

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

Patient Problems Capsular Contracture (1761); Corneal Decompensation (1790); Eye Injury (1845); Uveitis (2122); Vitreous Loss (2142); Capsular Bag Tear (2639); Eye Infections (4466); Toxic Anterior Segment Syndrome (TASS) (4469); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Explant date: not applicable, as lens was not explanted.Device evaluation: the product testing could not be performed as the product was not returned (the lens remains implanted).The reported complaint cannot be confirmed.Manufacturing record evaluation: the manufacturing record review could not be performed because the serial number of the complaint product is unknown.Since the serial number is unknown, the complaint history review could not be performed.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.Since no complaint product was returned, and serial number is unknown, it is not possible to determine a malfunction and/or product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.Citation: jung yeol choi, md,* young keun han, md, phdy,z, © 2018 published by elsevier inc.On behalf of canadian ophthalmological society.Https://doi.Org/10.1016/j.Jcjo.2018.08.005 issn 0008-4182.

Event Description

The following article was received based on a literature review: title: long-term (>=10 years) results of corneal endothelial cell loss after cataract surgery.A retrospective study was done to investigate the extent of long-term corneal endothelial loss after uneventful cataract surgery and the factors associated with decreases in corneal endothelial cell density (ecd).A total of 81 eyes of 48 patients underwent phacoemulsification with healon ovd (sodium hyaluronate 1%; jnj) to protect the endothelium and implantation of sensar ar40e hydrophobic acrylic intraocular lens (iol) (abbott medical optics).Exclusion criteria include complicated cataract surgery such as posterior capsule rupture, vitreous loss, laser iridotomy, conversion to extracapsular cataract extraction, iol decentration, exacerbated postoperative inflammation (toxic anterior segment syndrome, uveitis) with ocular hypertension, infection, and pseudoexfoliation.The mean 10-year ecd loss rate was 20.62 ± 13.63% from 2793 ± 351.09 cells/mm2 to 2148 ± 478.38 cells/mm2 due to post-op corneal edema.Five eyes of 3 patients lost 2 snellen lines due to epiretinal membrane (n=5).Three eyes of 2 patients lost more than 3 snellen lines due to age-related macular degeneration without exudative change (n=3).Twenty eyes of 18 patients required neodymium:yttrium-aluminium-garnet (nd: yag) laser capsulotomy due to posterior capsular opacity (n=20), and nd:yag anterior capsulotomy was performed in two eyes of 2 patients due to anterior capsule phimosis (n=2).Further interventions were not reported.

• Brand Name: UNK_SENSAR
• Type of Device: MONOFOCAL IOL
• 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: 11674961
• MDR Text Key: 261747083
• Report Number: 2648035-2021-07593
• 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: 03/17/2021
• 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