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

Model Number	ISERT 250 (+24 OD)
Health Effect - Clinical Codes	Vitreous Loss (2142); Capsular Bag Tear (2639)
Date of Event	06/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Regarding device evaluated by mfr? of this report, hoya device has not yet been returned for evaluation.(b)(4).
Event or Problem Description
It was reported that the patient experienced a vitreous leak and a spilt in the posterior capsule when the lens was inserted.The lens was cut out of the bag and another lens model was placed in the sulcus.In the surgeon's opinion, the likely cause of the event was "spilt in capsule bag.".
Additional Manufacturer Narrative
Complaint evaluation details from qa (b)(6): the lens was ejected out from the injector.Cracked line was observed on the lens.The entire injector was not returned.The leading haptic was deformed.Trace of lubricant was found on the lens.No abnormalities were found in production and inspection records of the product.Internal reference: (b)(4).
Event or Problem Description
It was reported that the patient experienced a vitreous leak and a spilt in the posterior capsule when the lens was inserted.The lens was cut out of the bag and another lens model was placed in the sulcus.In the surgeon's opinion, the likely cause of the event was "spilt in capsule bag.".

• 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: 6750665
• Report Number: 3006723646-2017-00015
• Device Sequence Number: 13726994
• Product Code: HQL
• UDI-Device Identifier: 04547480480862
• UDI-Public: 04547480480862
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 10/16/2017

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: 03/31/2020
• Device Model Number: ISERT 250 (+24 OD)
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/30/2017
• Supplement Date Received by Manufacturer: 06/30/2017
• Initial Report FDA Received Date: 07/28/2017
• Supplement Report FDA Received Date: 10/16/2017
• 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: 84 YR