MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. HOYA ISERT PRELOADED IOL SYSTEM; INTRAOCULAR LENS

Model Number	ISERT 251 (+18.00 OD)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Vitrectomy (2643)
Date of Event	08/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returning.(b)(4).
Event or Problem Description
Reportedly, the physician noticed the lens decentered post lens insertion into the patient's left eye and subsequently found a posterior capsule break.There was also vitreous loss.The lens was removed and a sulcus lens was implanted.The surgeon indicated the cause of the event is not known but the leading haptic may have caused posterior capsule break.The patient is doing well and no further treatment is anticipated at this time.

• Brand Name: HOYA ISERT PRELOADED IOL SYSTEM
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 15335 fairfield ranch road; suite 250; chino hills CA 91709
• MDR Report Key: 6904710
• Report Number: 3006723646-2017-00024
• Device Sequence Number: 1026399
• Product Code: HQL
• UDI-Device Identifier: 04547480450254
• UDI-Public: 04547480450254
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/30/2017

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: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: ISERT 251 (+18.00 OD)
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 09/29/2017
• 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
• Patient Age: 63 YR