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

Model Number	ISERT 250
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This initial emdr is being filed for like products reporting.Product recovery initiated.Device evaluation is pending return of product.After device evaluation is completed, a follow up report will be filed with fda.
Event or Problem Description
The trailing haptic failed to move down, trapped within the cartridge.The haptic had to be cut the as the** was already in the bag and the iol could not be released from the cartridge.A lot of extra and totally unnecessary manipulation inside the ac to dislocate the lens.To cut and remove the lens the incision needed to be increased and 2 extra sutures.Not a very good experience.Patient impact: lengthening of procedure.Patient outcome: unknown.
Additional Manufacturer Narrative
This follow-up report #1 is being filed for like products reporting for additional and corrected information not included/available in the initial report.

• 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: 7239328
• Report Number: 3006723646-2018-00006
• Device Sequence Number: 1022645
• Product Code: HQL
• UDI-Device Identifier: 04547480480879
• UDI-Public: 04547480480879
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2017

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: 05/31/2020
• Device Model Number: ISERT 250
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/12/2017
• Supplement Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 06/28/2018
• 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