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

Model Number	ISERT 230 (+29.00 D)
Medical Device Problem Code	Optical Decentration (1360)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	12/12/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 15335 farifield ranch rd.; suite 250; chino hills CA 91709
• MDR Report Key: 7754285
• Report Number: 3006723646-2018-00015
• Device Sequence Number: 1720490
• Product Code: HQL
• UDI-Device Identifier: 04547480301495
• UDI-Public: 04547480301495
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Expiration Date: 12/31/2019
• Device Model Number: ISERT 230 (+29.00 D)
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 08/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other