MAUDE Adverse Event Report: HOYA SURGICAL OPTICS, INC. B1PC; INTRAOCULAR LENS

Model Number	B1PC (+11.50 D)
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
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.Regarding 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
Trailing haptic sheered off when injecting iol.Product replaced with another lens immediately during surgery; 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 for a reportable malfunction that occurred in the usa.The report includes corrected and additional information not available/included in the initial report.Corrected information: d9 - corrected to "no", h3 - corrected to "product not returned".Additional information: g2 - added source - company representative, g6 - indicated follow-up #1, h2 - indicated report includes additional information, h6 - added codes for manufacturer's investigation: type; findings; and conclusion.The product was not returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.The product has not been returned as of 05 june 2021.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(6); model: b1pc).There were not any abnormalities on the loop pull strength test record of the material lot.(sotb-115-05).In addition, research in our complaint database indicated there were not any similar complaints in the same production lot numbers.The exact root cause was not determined.However, 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
Trailing haptic sheered off when injecting iol.Product replaced with another lens immediately during surgery; patient health not impacted; patient has recovered and is fine; no permanent or negative impact on patient health expected.

• Brand Name: B1PC
• 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: 11896099
• Report Number: 3006723646-2021-00034
• Device Sequence Number: 3633787
• Product Code: HQL
• UDI-Device Identifier: 00886158017035
• UDI-Public: 00886158017035
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2021

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: 09/30/2023
• Device Model Number: B1PC (+11.50 D)
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2021
• Supplement Date Received by Manufacturer: 05/23/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1