MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. PY60ADSE; INTRAOCULAR LENS

Model Number PY60ADSE (+23.00 D)

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Failure of Implant (1924)

Event Date 10/20/2022

Event Type  Injury  

Event Description

Event occurred in (b)(6).Damaged haptic after implantation.The damaged haptic was removed from the patient's eye and the iol was explanted and replaced by another lens, immediatly during surgery.According to the complaint information available, a permanent and/or neagtive impact on the patient's health is not to be expected at this time.

Manufacturer Narrative

This initial emdr is being submitted to fda for outside us like products reporting.Haptic damage is indicated as a potential malfunction related to the iol, as covered under the warnings section of the product's instructions for use (ifu).Regarding section h6 - manufacturer's codes for: type of investigation, findings, and conclusion are pending 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 type of investigation, findings, and conclusion.

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: h3 - 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 corrected information and 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.The iol was available for investigation.No abnormalities were found in production and inspection records of the product.(serial no.: tkm303p9; model: py60adse).We also confi rmed there were not any abnormalities on theloop pull strength test record of the material lot.(syut-60-03).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.

Event Description

Event occurred in germany.Damaged haptic after implantation.The damaged haptic was removed from the patient's eye and the iol was explanted and replaced by another lens, immediately during surgery.According to the complaint information available, a permanent and/or negative impact on the patient's health is not to be expected at this time.

• Brand Name: PY60ADSE
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): HOYA SURGICAL OPTICS, INC.; 525 technology drive; suite 280; irvine CA 92618
• Manufacturer (Section G): HOYA MEDICAL SINGAPORE PTE LTD; 455a jalan ahmad ibrahim; singapore, singapore 63993 9; SN 639939
• Manufacturer Contact: goutham pendyala ; 525 technology drive; suite 280; irvine, CA 92618 ; 9093896317
• MDR Report Key: 15756452
• MDR Text Key: 303296278
• Report Number: 3006723646-2022-00156
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P080004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PY60ADSE (+23.00 D)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2022
• 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