MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. HOYA ISERT 251; INTRAOCULAR LENS

Model Number	HOYA ISERT 251 (+22.00 D)
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This initial emdr is being submitted to fda for outside us like products reporting.Manufacturer's codes for: method, results, and conclusion are pending device return and completion of product investigation.Once the product investigation is completed, a follow-up report will be submitted to fda which will include the manufacturer's codes for method, results, and conclusion.
Event or Problem Description
On (b)(6) 2019 at 10 am, the patient was accepted the surgery of cataract phaco and iol implantation.After implantation, doctor found the optic of lens was insert into patient eye, however haptic were remain at injector, doctor considered that the iol has been cracked or broken.In order to prevent from injury to the patient, doctor explanted the cracked iol from patient eye at 10:05am and replaced a new iol to continue with surgery.Finally, it has been done successfully, there was no injury to patient.Patient impact: intra-operative explantation.Event occurred in (b)(6), and was reported by the hospital as ae to (b)(6) authority.
Event or Problem Description
On (b)(6) 2019 at 10 am, the patient was accepted the surgery of cataract phaco and iol implantation.After implantation, doctor found the optic of lens was insert into patient eye, however haptic were remain at injector, doctor considered that the iol has been cracked or broken.In order to prevent from injury to the patient, doctor explanted the cracked iol from patient eye at 10:05am and replaced a new iol to continue with surgery.Finally, it has been done successfully, there was no injury to patient.Patient impact: intra-operative explantation.Event occurred in china, and was reported by the hospital as ae to chinese authority.
Additional Manufacturer Narrative
This follow-up #1 emdr is being submitted to fda for outside us like products reporting.This report includes corrected information and additional information not available/included in the initial report, in the following sections: d10 - device available? - corrected to yes; and added the returned date.G7 - type of report - noted as follow-up #1.H2 - noted this report contains "corrected information" and "additional information".H3 - device evaluated by manufacturer? - corrected to yes.H6 - manufacturer's codes - added codes for: method; results; and conclusion.The device was returned to the manufacturer, and the product investigation was conducted.The results are noted below: the lens was cut and explanted from the patient eye.The trailing haptic was torn at root and remained in the injector.Tip of the haptic (pmma part) remained around tip of the slider, and the other part (acrylic part) remained under the slider.Tip of the nozzle was broken.Trace of lubricant was found in the injector tip.The dye test result showed the injector tip was properly coated.And new lens was re-installed inside the received tip and released but the lens came out without any problems.No abnormalities were found in production and inspection records of the product.(serial no.: tbi716f3; model: 251) exact root cause is not determined.From our investigation, we assume this issue is not product related.Risk analysis conducted on the product line and failure codes is noted below: a review of the most recent complaint trending data indicates that no significant trends have been identified at this time and no capa is required as part of the product evaluation.

• Brand Name: HOYA ISERT 251
• 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: 8976751
• Report Number: 3006723646-2019-00096
• Device Sequence Number: 2883670
• Product Code: HQL
• UDI-Device Identifier: 04547480450339
• UDI-Public: 04547480450339
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: HOYA ISERT 251 (+22.00 D)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 10/10/2019
• 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