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

Model Number	ISERT 250 (+22.00 OD)
Health Effect - Clinical Codes	Eye Injury (1845); Clouding, Central Corneal (2228)
Date of Event	10/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results: 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.
Event or Problem Description
The surgeon removed a fragment of haptic from the iol implant from the anterior chamber.Patient had cataract surgery on (b)(6) 2017, no problems noted at the time but on review appointment apparent that the cornea was oedematous.Subsequently referred to dr.For opinion and apparent that there was a blue end of the haptic of the lens implant in the front chamber of the eye.There have been other occurrences of the back haptic tearing off while being injected, but was obviously damaged at the time but not apparent, and it has subsequently become completely detached and loose in the anterior chamber, damaging the endothelial cells and causing the cornea to become cloudy.Patient information- patient outcome remains unknown, however action taken by the healthcare facility to the care of the patient: removing the fragment to prevent further damage was the first step.The cornea has cleared somewhat since.Time will tell whether the cornea will clear fully, or if the patient will require an endothelial corneal transplant.

• Brand Name: HOYA ISERT 250
• 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: 7183354
• Report Number: 3006723646-2018-00001
• Device Sequence Number: 1177084
• Product Code: HQL
• UDI-Device Identifier: 04547480480824
• UDI-Public: 04547480480824
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/11/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: ISERT 250 (+22.00 OD)
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 01/11/2018
• 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