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

Model Number	ISERT 250 (+19.50 OD)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Regarding this report, hoya device will not be returned for evaluation.Internal reference: (b)(4).
Event or Problem Description
The consumer reported having cataract surgery, and the afternoon after the surgery the surgeon looked at this eye and reportedly said the lens is not positioned properly.The consumer was referred to another doctor to have the lens repositioned.Additional information has been requested, but no additional information has been received.
Additional Manufacturer Narrative
Based on additional information, this event is determined to be unrelated to the device, and therefore is no longer considered reportable.Hoya device will not be returned for evaluation.Internal reference: (b)(4).
Event or Problem Description
The consumer alleged first that the doctor attributed his visual issues to a faulty lens.The consumer then went to a retinal specialist and this doctor told him he had a retinal tear and it was not the fault of the lens.He had the tear repaired and is seeing better.The consumer was in a car accident 25 years ago and the eye was injured so he might have had the retinal tear since then.Based on this additional information, this event is determined to be unrelated to the device, and therefore is no longer considered reportable.

• 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: 6752566
• Report Number: 3006723646-2017-00019
• Device Sequence Number: 137225
• Product Code: HQL
• UDI-Device Identifier: 04547480480770
• UDI-Public: 04547480480770
• Combination Product (Y/N): N
• 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: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2017

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 Model Number: ISERT 250 (+19.50 OD)
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/11/2017
• Supplement Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 07/28/2017
• Supplement Report FDA Received Date: 08/29/2017
• 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