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

Model Number	ISERT 250 (+15.00 D)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Return of hoya device has been requested by the distributor (b)(4).Once the device is received by the manufacturer, a product investigation will be conducted.Once the product investigation is completed, manufacturer will submit a follow-up report to fda.Internal reference: (b)(4).
Event or Problem Description
A mechanical error reportedly occurred during the procedure, the plunger damaged the lens haptic.There was patient contact and the incision was widened, no sutures were required.Additional information has been requested but has not been received.
Additional Manufacturer Narrative
Follow-up report #1 is being submitted to fda for the following reasons: corrected information: contact office - revised to reflect current contact person.Additional information not available/included in the initial report - findings from the manufacturer's product/complaint investigation, as noted below: returned iol condition: the lens was divided into two pieces and ejected out from the injector tip.Only half of the broken optic was returned.The entire injector was not returned.No abnormalities were found in production and inspection records of the product.Possible causes: exact root cause is not determined.From our investigation, we believe this issue is not product related.Additional information - not available/included in the initial report - added manufacturer's event problem and evaluation codes for: patient; device; method; results; and conclusion.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 product evaluation.This event can now be considered closed.

• 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 91709
• MDR Report Key: 7335611
• Report Number: 3006723646-2018-00009
• Device Sequence Number: 539995
• Product Code: HQL
• UDI-Device Identifier: 04547480480688
• UDI-Public: 04547480480688
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,health profession
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2018

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: 01/31/2020
• Device Model Number: ISERT 250 (+15.00 D)
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/14/2018
• Supplement Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 06/05/2018
• 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