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

Model Number	HOYA 250 ISERT (+29.50 OD)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Regarding this report, hoya device has not yet been returned.(b)(4).
Event or Problem Description
It was reported that the lens cracked as the lens was moving through the inserter during implantation.The incision was enlarged to remove the lens.Another model lens was then implanted.
Additional Manufacturer Narrative
Complaint evaluation details from (b)(6): s/n (b)(4) - the lens was ejected out from the injector tip.The lens was divided into two pieces.The slider and the rod could advance fully.Trace of lubricant was found inside the injector tip.(b)(4).
Event or Problem Description
It was reported that the lens cracked as the lens was moving through the inserter during implantation.The incision was enlarged to remove the lens.Another model lens was then implanted.

• 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: 6360883
• Report Number: 3006723646-2017-00002
• Device Sequence Number: 19076310
• Product Code: HQL
• UDI-Device Identifier: 04547480480978
• UDI-Public: 04547480480978
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2017

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: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: HOYA 250 ISERT (+29.50 OD)
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/02/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2017
• Supplement Report FDA Received Date: 03/10/2017
• 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: Required Intervention