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

Model Number	TMICL13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	02/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight: unk.Ethnicity: unk.Race: unk.This product is not marketed in the us.Claim# (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm tmicl13.2, -12/1.0/087 (sphere/cylinder/axis), implantable collamer lens into the patient's left eye (os) on (b)(6) 2021.A new pi and yag was performed on (b)(6) 2021.The lens was exchanged with a shorter length lens due to excessive vault and pupil block with elevated iop(34mmhg assessed on (b)(6) 2021) on (b)(6) 2021.This resolved the problem.Cause of the event is reported as device, "patients sulcus is an anatomical varianet from the normal which resulted in higher vault than expected with the fda nomogram.".
Additional Manufacturer Narrative
Additional information: b5 - the reporter indicated that the surgeon implanted a 13.2mm tmicl13.2, -12/1.0/087 (sphere/cylinder/axis), implantable collamer lens into the patient's left eye (os) on (b)(6) 2021.A new pi and yag was performed on (b)(6) 2021.The lens was explanted on (b)(6) due to excessive vault and pupil block with elevated iop(34mmhg assessed on (b)(6) 2021.A shorter length lens was implanted (b)(6) 2021, in a second surgery on (b)(6) 2021.This resolved the problem.Cause of the event is reported as device, "patients sulcus is an anatomical varianet from the normal which resulted in higher vault than expected with the fda nomogram." correct information: h6 - health effect-impact code - reported as 4629 - correct to 4627.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: b5: the pupil issue was a result of the initial surgery not the replacement.The patient is doing well with all other side effects besides the pupil resolved.The cause of the event is reported as device.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
• MDR Report Key: 11721925
• Report Number: 2023826-2021-01038
• Device Sequence Number: 3765862
• Product Code: QCB
• UDI-Device Identifier: 00841542109369
• UDI-Public: 00841542109369
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2021

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: 09/30/2022
• Device Model Number: TMICL13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 04/26/2021; 12/03/2021
• Initial Report FDA Received Date: 04/25/2021
• Supplement Report FDA Received Date: 04/26/2021; 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2020
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR
• Patient Sex: Female