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

Model Number	ISERT 250 (+22.00 OD)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hoya device has not yet been returned for evaluation.Internal reference: b&l (b)(4).
Event or Problem Description
It was reported that there was a broken capsule.Additional information has been requested but has not been received.
Additional Manufacturer Narrative
Regarding of this report, (b)(4) device has not yet been returned for evaluation.(b)(4).
Event or Problem Description
It was reported that there was a broken capsule.Additional information has been requested but has not been received.
Additional Manufacturer Narrative
Complaint evaluation details from qa (b)(4).The lens was ejected out from the injector tip.The slider and the rod could advance fully.The leading and the trailing haptic were broken at the blue pmma tip.The slider and the rod could advance fully.Trace of lubricant was found inside the injector tip and on the lens.Review of the production, inspection and sterilization records show no nonconformities and/or deviations from the specifications.Internal reference: (b)(4).
Event or Problem Description
It was reported that there was a broken capsule.Additional information has been requested but has not been received.

• 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: 6552133
• Report Number: 3006723646-2017-00009
• Device Sequence Number: 1170190
• Product Code: HQL
• UDI-Device Identifier: 04547480480824
• UDI-Public: 04547480480824
• 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
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2017

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: 07/31/2019
• Device Model Number: ISERT 250 (+22.00 OD)
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/10/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/08/2017
• Supplement Report FDA Received Date: 05/12/2017; 05/26/2017
• 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: Other