MAUDE Adverse Event Report: STAAR SURGICAL COMPANY SEE H10; INTRAOCULAR LENS

Model Number	CQ2015A
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information: unk.Brand name: collamer ultraviolet-absorbing posterior chamber three piece foldable intraocular lens.Lens work order search-no similar complaint type events reported for units within the same lot.Claim# (b)(4).
Event or Problem Description
Reportedly, a cq2015a intraocular lens, diopter +20.0 was received with a white speck on it.A back-up lens was implanted.There was no patient contact with the lens.
Additional Manufacturer Narrative
Additional information: h3-device evaluation: lens returned in a micro-centrifuge vial in liquid.Visual inspection found small speck optic of lens was noted at 2x.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: h6-method code 3331- based on the results of the investigation, one of the compositions of the particulate found on lens is likely to be collamer material particulates generated during the machining process.We are unable to determine any definitive root cause for this event.The cq2015a product line has been discontinued as of 2019, thus no further action is necessary.There is no indication that suggests a deficiency in the manufacturing process, further action is not required at this time.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: h6- method code 3331 and 4112: based on the results of the investigation, one of the compositions of the particulate found on lens is likely to be collamer material particulates generated during the machining process.We are unable to determine any definitive root cause for this event.Operators involved in the manufacturing of this nonconforming lens will be retrained in identification of cosmetic defects such as particulates on lens.There is no indication that suggests a deficiency in the manufacturing process, further action is not required at this time.Claim#: (b)(4).

• Brand Name: SEE H10
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 12361960
• Report Number: 2023826-2021-03281
• Device Sequence Number: 3822024
• Product Code: HQL
• UDI-Device Identifier: 00841542101981
• UDI-Public: 00841542101981
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P990013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/28/2021

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: 01/31/2022
• Device Model Number: CQ2015A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 10/12/2021; 11/05/2021; 01/31/2022
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 11/07/2021; 12/03/2021; 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2020
• 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
• Patient Sex: Unknown