MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. HOYA ISERT 250; INTRAOCULAR LENS

Model Number	ISERT 250 (+22.50D)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results of manufacturers final investigation: based on extensive experiments, it was concluded that the most likely cause of the observed haptic breakage is a combination of moving the slider fast forward while applying upward force to the slider.This movement may cause the lens-downholder to deform, and if this happens an edge of the lens-downholder intended to guide the plunger applies unintended shear force on the trailing haptic.This unintended shear force may damage the haptic when it is pushed in its folded position, which can result into breakage of the trailing haptic as been observed in our experiments.This scenario is a double fault condition with respect to the directions given in the ifu.The ifu has been reviewed and it is concluded that the steps described are sufficiently clear to prevent the failure mechanism from happening, if customers adhere to the instructions provided.
Event or Problem Description
It was reported that one of the "legs" (haptic) was almost completely off.This was noticed when the lens was close to being fully implanted.The lens was then removed and replaced.Patient outcome is unknown at this time.

• Brand Name: HOYA ISERT 250
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 15335 fairfield ranch rd.; suite 250; chino hills, ca
• Manufacturer (Section G): HOYA CORPORATION MEDICAL DIVISION; 2-7-5 naka-ochiai; shinjuku-ku; tokyo, 161-8 525; JA 161-8525
• Manufacturer Contact: corina pierson ; 15335 fairfield ranch rd.; suite 250; chino hills, ca ; 6803900
• MDR Report Key: 5736135
• Report Number: 3006723646-2016-00017
• Device Sequence Number: 13628616
• Product Code: HQL
• UDI-Device Identifier: 04547480480831
• UDI-Public: 04547480480831
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: ISERT 250 (+22.50D)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2016
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2016
• Supplement Date Received by Manufacturer: 06/13/2016
• Initial Report FDA Received Date: 06/20/2016
• Supplement Report FDA Received Date: 06/20/2016
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown