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

Model Number	PREVUE C (+19.00 D)
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This initial emdr is being submitted to fda as a reportable malfunction that occurred in the usa.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).Type of investigation, findings, 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 type of investigation, findings, and conclusion.
Event or Problem Description
Damaged haptic after implantation.The blue pmma tip of the leading haptic had sheared; the sheared blue pmma leading haptic did not enter into the eye.Product replaced with another lens immediately during surgery; no incision enlargement or sutures required; patient health not impacted.
Additional Manufacturer Narrative
This follow-up #1 emdr is being submitted to fda for a reportable malfunction that occurred in 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 device return.G2 - added source - company representative.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.The product was 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.: (b)(6), model: prevue c).We also confirmed there were not any abnormalities on the loop pull strength test record of the material lot.(sotj-g115-07) in addition, research in our complaint database indicated there were not any similar complaints in the same production lot numbers.Appearance check result was consistent to reported information.The dye test result showed the injector tip was properly coated.Proper coating allows the lens to advance through the tip.We could release a re-installed iol from the returned injector without any problems.The exact root cause was not determined in this case.However, from our investigation, 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 or Problem Description
Damaged haptic after implantation.The blue pmma tip of the leading haptic had sheared; the sheared blue pmma leading haptic did not enter into the eye.Product replaced with another lens immediately during surgery; no incision enlargement or sutures required; patient health not impacted.

• Brand Name: PREVUE C
• 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: 12304983
• Report Number: 3006723646-2021-00061
• Device Sequence Number: 12036294
• Product Code: HQL
• UDI-Device Identifier: 10757770564139
• UDI-Public: 10757770564139
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2021

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: 01/31/2024
• Device Model Number: PREVUE C (+19.00 D)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1