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

Model Number	TMICL 12.6
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explant date:unknown.Claim#: (b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm tmicl 12.6 implantable collamer lens of -11.5/3.0/091 (sphere/cylinder/axis) was implanted into the patient's left eye (os) on (b)(6) 2022.The lens was removed due to the lens implanted upside down.A replacement lens of the same model and size was implanted and the problem was resolved."improvements in os after replacement/exchange.Slight residual astigmatism.Continue muro 128, prolensa, inveltys with change to flarey when out of inveltys.Cause reported as unknown.Lens did not fail to perform as intended.Further clarification has been requested, but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
B5-the reporter indicated that a 12.6mm tmicl 12.6 implantable collamer lens of -11.5/3.0/091 (sphere/cylinder/axis) was implanted into the patient's left eye (os) on (b)(6) 2022.On (b)(6) 2022 the lens was removed and the backup lens of same model and size was implanted due to the lens implanted upside down.Reportedly, the problem was resolved."improvements in os after replacement/exchange.Slight residual astigmatism due to "high amounts of cyl pre op.Continue muro 128, prolensa, inveltys with change to flarey when out of inveltys.Cause reported as unknown.Lens did not fail to perform as intended.D6b- (b)(6) 2022.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: 13795877
• Report Number: 2023826-2022-00781
• Device Sequence Number: 14408645
• Product Code: QCB
• UDI-Device Identifier: 00841542107099
• UDI-Public: 00841542107099
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 02/14/2022

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: 03/31/2023
• Device Model Number: TMICL 12.6
• 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: 02/14/2022
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2021
• 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# UNK.; FOAM TIP PLUNGER (FTP), LOT# UNK.; INJECTOR MODEL: MSI-TF, LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 YR
• Patient Sex: Female