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

Model Number	B1PC (+18.50 D)
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	07/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This initial and final 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).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 5 august 2021.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(4); model: b1pc).We also confirmed 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 number.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 broke while implanting.Lens had to be explanted; some bleeding occurred; product replaced with another lens immediately during surgery; patient has recovered and is fine.

• 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: 12305043
• Report Number: 3006723646-2021-00065
• Device Sequence Number: 5096976
• Product Code: HQL
• UDI-Device Identifier: 00886158017172
• UDI-Public: 00886158017172
• Combination Product (Y/N): N
• 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: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/30/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: B1PC (+18.50 D)
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 08/10/2021
• 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