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

Model Number	HOYA ISERT 251 (+24.50 D)
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/22/2019
Type of Reportable Event	Malfunction
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
Peeling haptic during use.Patient impact: no impact.Only prolonged surgery time while back-up lens implanted with no harm to patient.It occurred in (b)(6), there was no impact to patient, but it was reported as ae to local authority by hospital.
Event or Problem Description
Peeling haptic during use.Patient impact: no impact.Only prolonged surgery time while back-up lens implanted with no harm to patient.It occurred in china, there was no impact to patient, but it was reported as ae to local authority by hospital.
Additional Manufacturer Narrative
This follow-up #1 emdr is being submitted to fda for outside us like products reporting.The product was not returned.Therefore, the product complaint investigation consisted of a review of manufacturing and production records.The results of the investigation are noted below.The product has not been returned as of 27 march 2020.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(6); model: 251) exact root cause is not determined.From our investigation, we assume this issue is not product related.A review of the most recent trending report indicates that no significant trends have been identified for the product and failure codes.No capa is required as part of the product investigation.

• 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: 9419413
• Report Number: 3006723646-2019-00105
• Device Sequence Number: 2491460
• Product Code: HQL
• UDI-Device Identifier: 04547480450384
• UDI-Public: 04547480450384
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: HOYA ISERT 251 (+24.50 D)
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2019
• Supplement Date Received by Manufacturer: 11/16/2019
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1