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

Model Number	B1PC (+19.00 D)
Medical Device Problem Code	Unintended Ejection (1234)
Health Effect - Clinical Codes	Hyphema (1911); Failure of Implant (1924)
Date of Event	07/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This initial emdr is being submitted to fda as a reportable malfunction that occurred in the usa."hyphema" is indicated as a potential adverse event related to iol implantation as covered under the warnings section of the product's instructions for use (ifu).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
Intra-operative complications; iol release issue.Surgeon stated that lens unfolded very fast, lens had already started to unfold as the lens entered the capsule.Some bleeding of the iris occurred while trying to put the lens into the bag.Surgeon was not able to get the lens into the bag without the potential for further complications.Device was explanted and replaced with another lens immediately during surgery.Patient impact: device explantation.Patient has recovered and is fine.
Event or Problem Description
Intra-operative complications; iol release issue.Surgeon stated that lens unfolded very fast, lens had already started to unfold as the lens entered the capsule some bleeding of the iris occurred while trying to put the lens into the bag surgeon was not able to get the lens into the bag without the potential for further complications.Device was explanted and replaced with another lens immediately during surgery.Patient impact: device explantation.Patient has recovered and is fine.
Additional Manufacturer Narrative
This follow-up #1 emdr is being submitted to fda for a reportable event that occurred in the usa.The report includes corrected information and additional information not available/included in the initial report.Corrected information: h3 - corrected to device not returned.Additional information: g6 - type of report - noted as follow-up #1.Portions of the product were returned to the manufacturer.The investigation was conducted, with the methods and results as noted below.The injector was available for investigation.The iol was not returned.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(6); model: b1pc).The dye test result showed the injector tip was properly coated.Proper coating allows the lens to advance.We could release a re-installed iol from the returned injector without any problems.From our investigation, we could not confirm the reported event.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.

• Brand Name: B1PC
• Common Device Name: 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: 15294441
• Report Number: 3006723646-2022-00132
• Device Sequence Number: 6192630
• Product Code: HQL
• UDI-Device Identifier: 00886158017189
• UDI-Public: 00886158017189
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P080004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2022

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 Model Number: B1PC (+19.00 D)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown