MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. HOYA ISERT 230; INTRAOCULAR LENS

Model Number ISERT 230 (+29.00 D)

Device Problem Optical Decentration (1360)

Patient Problem Visual Disturbances (2140)

Event Date 12/12/2017

Event Type  Injury  

Manufacturer Narrative

This initial report is being submitted to fda based on the planned delayed surgical intervention.The device is currently still implanted in the patient; therefore, the product complaint investigation consisted of a review of the manufacturing processes and inspection records.No abnormalities were found.As a result of the investigation, we believe this event is not device related.

Event Description

Per the data collection form: original multifocal implantation [from a different manufacturer] created significant glare and halos; original surgery date os, (b)(6) 2016.Iol exchange monofocal [from this manufacturer] for multifocal - date of surgery (b)(6) 2017.Date of onset/problem: (b)(6) 2017.Problem/event: lens exchange multifocal for monofocal os; lens placed in sulcus os; moderate but stable inferior centration, optic still within undilated pupil causing symptoms of intermittent monocular diplopia.Inferior decentration os, noted (b)(6) 2017.Secondary surgical intervention is pending iol exchange os for another monofocal in sulcus.Surgeon in process of researching monofocal sulcus lens options for 2nd monofocal exchange procedure - tbd.In the surgeon's opinion, the likely cause of the event: changes to the integrity of the sulcus and capsule related to implantation then subsequent exchange of original multifocal iol os.Patient's prognosis & treatment: good prognosis.Tbd which monofocal model to be used in second lens exchange os.

• Brand Name: HOYA ISERT 230
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 15335 farifield ranch rd.; suite 250; chino hills CA 91709
• Manufacturer (Section G): HOYA MEDICAL SINGAPORE PTE LTD; 455a jalan ahmad ibrahim; singapore, singapore 63993 9; SN 639939
• Manufacturer Contact: goutham pendyala ; 15335 fairfield ranch rd.; suite 250; chino hills, CA 91709 ; 9093896317
• MDR Report Key: 7754285
• MDR Text Key: 116152445
• Report Number: 3006723646-2018-00015
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 04547480301495
• UDI-Public: 04547480301495
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 12/31/2019
• Device Model Number: ISERT 230 (+29.00 D)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2018
• Initial Date FDA Received: 08/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2016
• 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): Other