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

Model Number	ISERT 250 (+21.00 D)
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	06/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by manufacturer? no.Device return has been requested by the distributor, but the device has not yet been received by the manufacturer.Once the device is returned, the manufacturer will conduct a product investigation.After the device is returned, and the manufacturer completes the product investigation, these codes will be provided in a follow-up report to fda.
Event or Problem Description
It was reported that the haptic broke off upon insertion and the incision was enlarged to remove the lens intraoperatively.The lens was replaced with the same type and diopter lens.No sutures were required.Patient prognosis is good, although it was noted that there may be more than the usual swelling post-surgery.
Event or Problem Description
It was reported that the haptic broke off upon insertion and the incision was enlarged to remove the lens intraoperatively.The lens was replaced with the same type and diopter lens.No sutures were required.Patient prognosis is good, although it was noted that there may be more than the usual swelling post-surgery.
Additional Manufacturer Narrative
Follow-up report #1 is being submitted to fda for the following reasons: corrected information: device evaluated? corrected to yes additional information not available/included in the initial report - risk analysis conducted on the product line and failure code, as noted below: a review of the most recent complaint trending data indicates no significant trends have been identified at this time, and no capa is required as part of the product evaluation.This event can now be considered closed.

• Brand Name: HOYA ISERT 250
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 15335 fairfield ranch rd.; suite 250; chino hills CA 91709
• MDR Report Key: 7835453
• Report Number: 3006723646-2018-00019
• Device Sequence Number: 16639399
• Product Code: HQL
• UDI-Device Identifier: 04547480480800
• UDI-Public: 04547480480800
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: ISERT 250 (+21.00 D)
• Initial Date Received by Manufacturer: 08/10/2018
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 10/22/2018
• 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