MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. HOYA ISERT 255; INTRAOCULAR LENS

Model Number HOYA ISERT 255 (+24.00 D)

Device Problem Misfocusing (1401)

Patient Problems Failure of Implant (1924); Visual Impairment (2138)

Event Type  Injury  

Manufacturer Narrative

This initial emdr is being submitted to fda for outside us like products reporting."error of predicted refractive power" is indicated as a potential adverse event related to iol implantation as noted in the ifu warnings section.Manufacturer's codes for: type of investigation, findings, and conclusion are pending completion of 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 type of investigation, findings, and conclusion.

Event Description

Date of implant: not reported.Refractive error; post-operative explant.The patient has hyperopia (around 3.0d) after implantation of this iol (+24.0d).On (b)(6) 2021, the doctor explanted the iol and implanted +27.50d iol.However, the patient got +3.0d myopia.

Event Description

Date of implant: not reported.Refractive error; post-operative explant, the patient has hyperopia (around 3.0d) after implantation of this iol (+24.0d).On (b)(6)2021, the doctor explanted the iol and implanted +27.50d iol.However, the patient got +3.0d myopia.

Manufacturer Narrative

This follow-up #1 emdr is being submitted to fda for a reportable event that occurred outside of the usa.The report includes corrected information and additional information not available/included in the initial report.Corrected information: d9 - device available - corrected to yes.H3 - device evaluated - corrected to yes.Additional information: d9 - added date of product return.G6 - type of report - noted as follow-up #1.H2 - type of follow-up - noted for additional information.H6 - added codes for manufacturer's investigation: type; findings; and conclusion.Portions of the product were returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.Portions of the product were returned to the manufacturer.The investigation was conducted with the methods and results as noted below.No abnormalities were found in production and inspection records of the product.(serial no.: tdl40254; model: 255).The injector was not returned.The lens was returned with damage to the center of the optic caused by the forceps during explantation.We could not perform the actual power measurement testing of the returned (used) lens using nidek and nimo as the lens was damaged.The exact root cause of the event was not determined.However, based on available information, we believe this event was not caused by our product quality.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 255
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 15335 fairfield ranch rd.; suite 250; chino hills CA 91709
• Manufacturer (Section G): HOYA CORPORATION; 6-10-1 nishi shinjuku; shinjuku-ku; tokyo, 160-0 023; JA 160-0023
• Manufacturer Contact: goutham pendyala ; 15335 fairfield ranch rd.; suite 250; chino hills, CA 91709 ; 9093896317
• MDR Report Key: 12728936
• MDR Text Key: 279318861
• Report Number: 3006723646-2021-00079
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P080004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: HOYA ISERT 255 (+24.00 D)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention