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

Model Number	ISERT 251 (+18.00 D)
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This initial emdr report is being submitted to fda for like products reporting.Regarding evaluation codes of this report - the manufacturer's codes for: method; results; and, conclusion - are pending completion of the manufacturer's product/complaint investigation.Once the investigation is completed, a follow-up report will be submitted to fda, which will include the manufacturer's codes for: method; results; and, conclusion.Note: regarding initial reporter address: the address entered is for (b)(6)."(b)(6)" was selected from the dropdown available in the current esubmitter software (rev.2.2, may 2018).However, the 2-letter abbreviation that appears on the report print out is (b)(6), when it should be (b)(6).
Event or Problem Description
Partial separation of part of the trailing haptic was noticed during implantation.Lens had to be explanted.New lens was implanted.Second implantation went well without harming the patient.Patient outcome: no patient impact.
Additional Manufacturer Narrative
This follow-up report #1 is being filed for like products reporting - to submit additional information not available/included in the initial report.Section g7 - type of report - indicated "follow-up #1".Section h2 - type of follow-up - indicated "additional information".Section h6 - event problem and evaluations codes: added codes for: method; results; and conclusion.Section h10 - additional information: device evaluation and risk analysis results.The device was not returned to the manufacturer.Therefore, the product complaint investigation consisted of a review of the production and inspection records, and the results are noted below: no abnormalities were found in the production and inspection records of the product.Exact root cause could not be determined.From our investigation, we believe this issue is not product related.Risk analysis conducted on the product line and failure codes, as noted below: a review of the most recent complaint trending data indicates no significant trends have been identified at this time, and no capa is required as part of product evaluation.
Event or Problem Description
Partial separation of part of the trailing haptic was noticed during implantation.Lens had to be explanted.New lens was implanted.Second implantation went well without harming the patient.Patient outcome: no patient impact.

• 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: 7948008
• Report Number: 3006723646-2018-00021
• Device Sequence Number: 856404
• Product Code: HQL
• UDI-Device Identifier: 04547480450254
• UDI-Public: 04547480450254
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2018

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: 02/28/2021
• Device Model Number: ISERT 251 (+18.00 D)
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 10/19/2018
• 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: Required Intervention