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

Model Number	TMICL 12.6
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6) 2024.Claim #(b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm tmicl 12.6 implantable collamer lens of -7.50/2.0/048 (sphere/cylinder/axis) was implanted into the patients left eye (os) (b)(6) 2022.On (b)(6) 2022 the lens was removed due to size.The lens was replaced on an unknown date with another staar lens.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Corrected data: b5: the reporter indicated that a 12.6mm tmicl 12.6 implantable collamer lens of -7.50/2.0/048 (sphere/cylinder/axis) was implanted into the patients left eye (os) (b)(6) 2022.On (b)(6) 2022 the lens was removed due to size.The lens was replaced on an unknown date with another staar lens.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.D6b: explant date-( b)(6) 2022.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm tmicl 12.6 implantable collamer lens of -7.50/2.0/048 (sphere/cylinder/axis) was implanted into the patients left eye (os) (b)(6) 2022.On (b)(6) 2022 the lens was removed due to size.The lens was replaced on an unknown date with another staar lens.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.

• 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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 15342351
• Report Number: 2023826-2022-02896
• Device Sequence Number: 5144028
• Product Code: QCB
• UDI-Device Identifier: 00841542106511
• UDI-Public: 00841542106511
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

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 Model Number: TMICL 12.6
• 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: 08/03/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown