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

Model Number AR40

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

Patient Problems Eye Injury (1845); Retinal Detachment (2047); Visual Impairment (2138); Vitreous Loss (2142); Capsular Bag Tear (2639)

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: age range between 56.1±14.1 years of age.Weight and ethnicity: unknown/not provided.Per eu regulation (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Date of event: article acceptance date is (b)(6) 2021.Model number: partially known, as the serial number was not provided.Catalog number: a complete catalog number is unknown, as the serial number was not provided.Serial number: unknown, information not provided.Expiration date: unknown, as serial number was not provided.Implant date: unknown/not provided.Explant date: unknown/not provided.The intraocular lens (iol) is not returning for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device is not possible as no serial number information was provided, 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 serial number was not provided.Gaurisankar, z.S., van rijn, g.A., cheng, y.Y.Y., luyten, g.P.M., beenakker, j-w.M.(2021).Two-year results after combined phacoemulsification and iris-fixated phakic intraocular lens removal.Graefe's archive for clinical and experimental ophthalmology.260(1), pp.1367¿1375.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

The following article was received based on literature review.Article: two-year results after combined phacoemulsification and iris-fixated phakic intraocular lens removal.A retrospective study was done to describe the surgical technique of performing cataract surgery underneath the phakic intraocular lens (piol) in patients, previously treated with an (toric) artisan or artifex (ophtec bv) iris-fixated phakic intraocular lens (if-piol) and present the safety and visual and refractive outcomes of this procedure.A total of 59 eyes of 40 patients underwent single incision technique (sit) for combined cataract surgery and piol explantation.The patients were divided into two groups: myopic eyes (n=50) and hyperopic eyes (n=9).The iol model chosen for implantation include the following: tecnis zcb00, pcb00, or za9003, and sensar ar40 (johnson &johnson); acrysof ma60ma and sa60at (alcon); or bigbag (carl zeiss meditec ag).The healon (johnson & johnson vision surgical) ophthalmic viscosurgical device (ovd) was also used during cataract surgery and injected into the anterior chamber to separate the piol from the crystalline lens.It was reported that the postoperative refractive cylinder of 17 eyes were not within =1.00 d.Overall postoperative endothelial cell density (ecd) loss was -5.4 ± 11.8% after 6 months and -9.4±17.0% after 6¿24 months which was interpreted to be as a result of surgical trauma.The postoperative spherical equivalent of one eye deviated -1.78 d from target refraction in which the patient received an additional toric if-piol 3 months after single incision technique (sit).Cataract surgery was complicated by a posterior capsular rupture in three eyes of which two eyes with vitreous loss.One myopic patient presented with a rhegmatogenous retinal detachment in one eye within 2 years after the sit procedure.It is not clear if these complications occurred in the eyes inserted with tecnis zcb00, pcb00, or za9003, sensar ar40 (johnson & johnson), or the other products.No additional information was provided.This report is for model sensar ar40 adverse event.Separate reports are being submitted to capture the reported zcb00, pcb00, and za9003 adverse events.

• Brand Name: SENSAR IOL
• 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 ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 13906233
• MDR Text Key: 288051443
• Report Number: 3012236936-2022-00739
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P980040
• 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: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AR40
• Device Catalogue Number: AR40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2022
• 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