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

Model Number	HOYA 250 ISERT (+18.50 OD)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	12/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was initially listed as "not reportable" and revised to "reportable." evaluation from qa (b)(4): mfr report#: 3006723646-2017-00007; uf/importer report#: form code: as the complaint product has not been returned from customer, visual inspection was not performed and further information could not be provided.According to the customer, the lens was implanted and removed due to the patient's eye pressure and unrelated to the lens.Internal reference: (b)(4).
Event or Problem Description
It was reported that the lens was removed intraoperatively from the patient's left eye due to a small capsule tear noted upon insertion.Another lens of different model was implanted successfully and the prognosis was reported as "good.".

• Brand Name: HOYA ISERT PRELOADED IOL SYSTEM
• 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 MEDICAL SINGAPORE PTE LTD; 455a jalan ahmad ibrahim; singapore, singapore 63993 9; SN 639939
• Manufacturer Contact: corina pierson ; 15335 fairfield ranch rd.; suite 250; chino hills, ca ; 6803900
• MDR Report Key: 6455450
• Report Number: 3006723646-2017-00007
• Device Sequence Number: 16318900
• Product Code: HQL
• UDI-Device Identifier: 04547480480756
• UDI-Public: 04547480480756
• Combination Product (Y/N): N
• 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): 04/03/2017

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: Other
• Device Expiration Date: 08/31/2019
• Device Model Number: HOYA 250 ISERT (+18.50 OD)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2016
• Supplement Date Received by Manufacturer: 12/27/2016
• Initial Report FDA Received Date: 04/03/2017
• Supplement Report FDA Received Date: 04/03/2017
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female