MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. BVI B3PC; INTRAOCULAR LENS

Model Number	BVI B3PC (+19.50 D)
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This initial emdr is being submitted to fda as a reportable adverse event that occurred in the usa.Manufacturer's codes for: 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
Iol got stuck in the nozzle during insertion.User error as tech pressed slider forward she likely disputed body of injector causing lens to split in half.Surgeon inserted split lens, widened incision and removed iol with no injury to patient.Patient impact: intra-operative explant increased incision size; product replaced with another lens immediately during surgery; increased incision required sutures to close; patient health not impacted; patient has recovered and is fine; no permanent or negative impact on patient health expected.
Additional Manufacturer Narrative
This follow-up #1 emdr is being submitted to fda as a reportable adverse event that occurred in the usa.The report includes additional information not available/included in the initial report.Parts of the product were returned to the manufacturer, and the investigation was conducted, with the methods and results as noted below.The iol was ejected out from the injector.The optic was broken from the edge at the root of one haptic and broken into two pieces.The injector was not returned.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(6); model: b3pc) in addition, research in our complaint database indicated there were not any similar complaints in the same production lot.From our investigation, we believe this event was not caused by our product quality.Risk analysis was conducted on the product line and failure code is noted below.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
Iol got stuck in the nozzle during insertion.User error as tech pressed slider forward she likely disputed body of injector causing lens to split in half.Surgeon inserted split lens, widened incision and removed iol with no injury to patient.Patient impact: intra-operative explant increased incision size; product replaced with another lens immediately during surgery; increased incision required sutures to close; patient health not impacted; patient has recovered and is fine; no permanent or negative impact on patient health expected.

• Brand Name: BVI B3PC
• 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: 10837781
• Report Number: 3006723646-2020-00019
• Device Sequence Number: 4178289
• Product Code: HQL
• UDI-Device Identifier: 00886158015772
• UDI-Public: 00886158015772
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: BVI B3PC (+19.50 D)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 01/20/2021
• 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