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

Model Number	TMICL13.7
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Pupillary Block (2026); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510k: this product is not marketed in the us.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.7mm tmicl13.7, -16.00/4.0/125 (sphere/cylinder/axis), implantable collamer lens into the patient's right eye (od) on (b)(6) 2021.The lens was exchanged with a for a shorter length lens due to pubil block with elevated iop(39mmhg), angle closure with elevated iop(39mmhg) assessed on (b)(6) 2021, and excessive vault, on (b)(6) 2020.This resolved the problem.Cause of the event is reported as user error.
Additional Manufacturer Narrative
Corrected data: b5: the reporter indicated that the surgeon implanted a 13.7mm tmicl13.7, -16.00/4.0/125 (sphere/cylinder/axis), implantable collamer lens into the patient's right eye (od) on (b)(6) 2021.The lens was exchanged with a for a shorter length lens on (b)(6) 2021 due to pubil block with elevated iop(39mmhg), angle closure with elevated iop(39mmhg) assessed on (b)(6) 2021, and excessive vault.This resolved the problem.Cause of the event is reported as user error.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data b5: the reporter indicated that the surgeon implanted a 13.7mm tmicl13.7, -16.00/4.0/125 (sphere/cylinder/axis), implantable collamer lens into the patient's right eye (od) on (b)(6) 2021.The lens was exchanged with a for a shorter length lens on (b)(6) 2021 due to pubil block with elevated iop(39mmhg), angle closure with elevated iop(39mmhg) assessed on (b)(6) 2021.This resolved the problem.Cause of the event is reported as user error.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
• MDR Report Key: 11515298
• Report Number: 2023826-2021-00652
• Device Sequence Number: 14422077
• Product Code: QCB
• UDI-Device Identifier: 00841542112086
• UDI-Public: 00841542112086
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2021

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: 12/31/2022
• Device Model Number: TMICL13.7
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 10/27/2021; 10/27/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 10/27/2021; 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL#SFC-45,LOT#UNK; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK; CARTRIDGE MODEL#SFC-45,LOT#UNK; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 YR