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

Model Number	ISERT 250 (+21.50 OD)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	11/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hoya device was not returned back from the customer.No abnormalities were found in production and inspection records of the product.(b)(4).
Event or Problem Description
It was reported that the lens haptic broke off during advancement of the device into the eye.The incision was possibly enlarged to remove the lens; however, no sutures were necessary.The back-up lens was then implanted with no issues.
Event or Problem Description
Follow-up report: it was stated that the trailing lens haptic was found to be missing after insertion of the lens.The broken haptic had remained inside the cartridge.It was also clarified that no incision enlargement or sutures were required for this surgery.The physician attributed the issue to the lens becoming stuck in the delivery device.Regarding the prognosis, the patient is doing well.Based on this information, the reported event is no longer considered serious.

• 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: 7100720
• Report Number: 3006723646-2017-00030
• Device Sequence Number: 1874147
• Product Code: HQL
• UDI-Device Identifier: 04547480480817
• UDI-Public: 04547480480817
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2018

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: 05/31/2020
• Device Model Number: ISERT 250 (+21.50 OD)
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 12/08/2017
• Supplement Report FDA Received Date: 01/05/2018
• 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
• Patient Age: 79 YR