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

Model Number	ISERT 250 (+23.50 D)
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed, a follow-up report will be submitted to the fda with the appropriate manufacturer's codes for - method, results, and conclusion.
Event or Problem Description
It was reported that the broken back haptic was noticed upon insertion.The lens was removed and replaced.The incision was enlarged (3.2mm) and 1 suture was placed.Patient outcome and treatment is good.
Additional Manufacturer Narrative
Follow-up report #1 is being submitted to fda for the following reasons: additional information not available/included in the initial report - findings from the manufacturer's product/complaint investigation, as noted below: the product was not returned for the investigation.Investigation on the lens and injector could not be performed.No abnormalities were found in production and inspection records of the product.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 "company representative".Noted this is follow-up #1.Noted reason for follow-up is "additional information" added manufacturer's codes for: 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 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: 7745312
• Report Number: 3006723646-2018-00014
• Device Sequence Number: 13804108
• Product Code: HQL
• UDI-Device Identifier: 04547480480855
• UDI-Public: 04547480480855
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 07/13/2018

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 (+23.50 D)
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2018
• Supplement Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 08/02/2018
• Supplement Report FDA Received Date: 08/03/2018
• 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