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

Model Number	TMICL12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Reportedly, a 12.6mm tmicl12.6 -16.00/1.5/068 implantable collamer lens was implanted into the patients left eye (od) on (b)(6) 2022.The lens was exchanged for a different model, length and power lens on an unknown date.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Lens work order search: no similar complaint type events reported for units within the same lot.Claim#:(b)(4).
Additional Manufacturer Narrative
H3: device evaluation: lens was returned in liquid, in vial.Visual inspection found a haptic and optic torn.Claim #(b)(4).
Additional Manufacturer Narrative
B4: corrected to 05-jul-2022 in initial mdr.B5: corrected to: reportedly, a 12.6mm tmicl12.6 -16.00/1.5/068 implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2022.The lens was exchanged for a different model, length and power lens on an unknown date.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.G3: corrected to 05-jul-2022 in initial mdr 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: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 15218330
• Report Number: 2023826-2022-02705
• Device Sequence Number: 12434342
• Product Code: QCB
• UDI-Device Identifier: 00841542107693
• UDI-Public: 00841542107693
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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,Followup
• Report Date (Section B): 07/05/2022

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: 07/31/2022
• Device Model Number: TMICL12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 10/04/2022; 12/01/2022
• Initial Report FDA Received Date: 08/12/2022
• Supplement Report FDA Received Date: 11/27/2022; 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown