MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC INTRAOCULAR LENS

Model Number	MICL12.6
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight - unk.Ethnicity - unk.Race - unk.(b)(4).Claim # (b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm micl12.6 implantable collamer lens, -11.00 diopter, in the patients right eye (od) on (b)(6) 2021.The lens was explanted on (b)(6) 2021 due to excessive vaulting and elevated intraocular pressure (iop).Aqueous was released from the chamber.The lens was replaced with a shorter lens and the problem was resolved.The cause of the event was unknown.
Additional Manufacturer Narrative
B3- corrected to (b)(6) 2021.B5- the reporter indicated the surgeon implanted a 12.6mm micl12.6 implantable collamer lens, -11.00 diopter, in the patients right eye (od) on (b)(6) 2021.The lens was explanted on (b)(6) 2021 due to excessive vaulting.Aqueous was released from the chamber.The lens was replaced with a shorter lens and the problem was resolved.Elevated intraocular pressure (iop) was reported as a post-operative condition.The cause of the event was unknown.H6- health effect- clinical code: removed code 1937 and replaced with code 4582.Claim# (b)(4).
Additional Manufacturer Narrative
B5: per email on 22-feb-2022, it was clarified that elevated iop was experienced after the initial lens was implanted.Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC 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 ; 6263037902
• MDR Report Key: 12669504
• Report Number: 2023826-2021-04033
• Device Sequence Number: 19192611
• Product Code: MTA
• UDI-Device Identifier: 00841542103046
• UDI-Public: 00841542103046
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2021
• Supplement Date Received by Manufacturer: 02/15/2022; 02/22/2022
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 02/15/2022; 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL SFC-45 - LOT # 1446792.; FOAM TIP PLUNGER MODEL FTP - LOT # 1546192.; INJECTOR MODEL MSI-PF - LOT # UNK.; CARTRIDGE MODEL SFC-45 - LOT # 1446792; FOAM TIP PLUNGER MODEL FTP - LOT # 1546192; INJECTOR MODEL MSI-PF - LOT # UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR
• Patient Sex: Female