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

Model Number	B3PC (+28.00 D)
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2021
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
Cracked or deformed cartridge/tip.Failure during implantation when physician was handling the lens.Lens was about 1/3 to 1/2 way into the eye when the injector tip split.Physician couldn't proceed with implant as tail end of the lens was coming through the split; device explanted.Patient impacted: no.
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: h3 - device evaluation - corrected to yes additional information: d9 - added date product was returned to manufacturer g2 - added source - company representative g6 - indicated follow-up #1 h2 - indicated report includes 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.The iol was found inside the nozzle part.The side part of the nozzle was cracked, a part of the optic was protruded from the crack and, leading haptic was protruded from the nozzle part.The optic was damaged.Trailing haptic was bent.The slider was completely advanced.The rod was advanced and contacted with trailing haptic.Trace of lubricant (cohesive) was found inside the injector.The dye test result showed the injector tip was properly coated.We could release a re-installed iol from the returned injector without any problems.No abnormalities were found in production and inspection records of the product.(serial no.: (b)(6); model: b3pc).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
Cracked or deformed cartridge/tip.Failure during implantation when physician was handling the lens.Lens was about 1/3 to 1/2 way into the eye when the injector tip split.Physician couldn't proceed with implant as tail end of the lens was coming through the split; device explanted.Patient impacted: no.

• Brand Name: 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: 11896106
• Report Number: 3006723646-2021-00035
• Device Sequence Number: 17052390
• Product Code: HQL
• UDI-Device Identifier: 00886158015949
• UDI-Public: 00886158015949
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 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: 05/31/2023
• Device Model Number: B3PC (+28.00 D)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• 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: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1