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

Model Number	TMICL12.6
Medical Device Problem Codes	Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight: unk.Ethnicity: unk.Race: unk.(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm tmicl12.6 implantable collamer lens, -17.50/+4.0/065 (sphere/cylinder/axis), into the patients left eye (os) on (b)(6) 2021.The lens was explanted on (b)(6) 2021 due to excessive vaulting, angle closure and elevated iop.The anterior chamber was irrigated/evacuated of visco/ fluids and the wound was burped, confirming there was no visco remaining.The pis were enlarged by yag.The problem was resolved and patient is no longer in pain.The iop has decreased significantly and angles are open.The cause of the event was due to the icl was too big, causing peripheral angle closure.
Additional Manufacturer Narrative
Weight: unk.Ethnicity: unk.Race: unk.(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm tmicl12.6 implantable collamer lens, -17.50/+4.0/065 (sphere/cylinder/axis), into the patients left eye (os) on (b)(6) 2021.The lens was explanted on (b)(6) 2021 due to excessive vaulting, angle closure and elevated iop.The anterior chamber was irrigated/evacuated of visco/ fluids and the wound was burped, confirming there was no visco remaining.The pis were enlarged by yag.The problem was resolved and patient is no longer in pain.The iop has decreased significantly and angles are open.The cause of the event was due to the icl was too big, causing peripheral angle closure.
Additional Manufacturer Narrative
H3: device evaluation : lens was returned in aa specimen cup dry.Visual inspection found no visible damage to the lens.Dimensional inspection found the lens to be within specification.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC 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: 12965310
• Report Number: 2023826-2021-04644
• Device Sequence Number: 4332279
• Product Code: QCB
• UDI-Device Identifier: 00841542107952
• UDI-Public: 00841542107952
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2021

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: 08/31/2023
• Device Model Number: TMICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL SFC-45 - LOT # 1544823.; FOAM TIP PLUNGER MODEL FTP - LOT # 1546192.; INJECTOR MODEL MSI-PF - LOT # UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Sex: Male