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

Model Number	FY60ADUS
Health Effect - Clinical Codes	Rupture (2208); Vitrectomy (2643)
Date of Event	09/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hoya device is pending evaluation.Internal reference: (b)(4).
Event or Problem Description
Reportedly, the lens was implanted and posterior capsule ruptured.The incision was enlarged and sutures were used.A vitrectomy was performed and anterior chamber lens was implanted.The patient's current status was described as "good, post-op cataract care.".
Additional Manufacturer Narrative
Regarding of this report, hoya device is pending evaluation.Additional information received for- date of event: (b)(6) 2017.Internal reference: (b)(4).
Event or Problem Description
Reportedly, the lens was implanted and posterior capsule ruptured.The incision was enlarged and sutures were used.A vitrectomy was performed and anterior chamber lens was implanted.The patient's current status was described as "good, post-op cataract care.".
Additional Manufacturer Narrative
Complaint evaluation details from qa (b)(6): returned iol condition: the lens and the both haptics were deformed.The optic was torn at the edge.No abnormalities were found in production and inspection records of the product.(b)(6).Internal reference: (b)(4).
Event or Problem Description
Reportedly, the lens was implanted and posterior capsule ruptured.The incision was enlarged and sutures were used.A vitrectomy was performed and anterior chamber lens was implanted.The patient's current status was described as "good, post-op cataract care.".

• 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: 6965655
• Report Number: 3006723646-2017-00025
• Device Sequence Number: 1364923
• Product Code: HQL
• UDI-Device Identifier: 04547480203133
• UDI-Public: 04547480203133
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/13/2017

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: 11/30/2020
• Device Model Number: FY60ADUS
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/02/2017
• Supplement Date Received by Manufacturer: 10/02/2017; 10/02/2017
• Initial Report FDA Received Date: 10/20/2017
• Supplement Report FDA Received Date: 10/30/2017; 11/13/2017
• 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: 80 YR