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

Model Number	TMICL13.2
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter states a 13.2mm tmicl13.2 implantable collamer lens -10.5/+2.0/087 (sphere/ cylinder/axis) was implanted into the patient's right (od) eye on (b)(6) 2021.Reportedly, the lens was explanted.Attempts to obtain additional information have not been successful.
Additional Manufacturer Narrative
H3: device evaluation: the lens was returned dry in a vial.There was residue/debris on the product.Visual inspection found that the haptic was torn and there was residue throughout the lens.Claim#: (b)(4).
Additional Manufacturer Narrative
B5-additional information: on (b)(6) 2021 the lens was explanted due to excessive vault.Iris chafing and lack of pupil constriction temporally due to excessive vault; caused cosmetic concerns of anisocoria is reported.Reportedly lasik is being considered at a later date to correct the vision.H6-health effect clinical code 4581 (iris chafing, lack of pupil constriction).Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• 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 ; 8002927902
• MDR Report Key: 12599777
• Report Number: 2023826-2021-03906
• Device Sequence Number: 17153356
• Product Code: QCB
• UDI-Device Identifier: 00841542109109
• UDI-Public: 00841542109109
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 09/15/2021

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: 04/30/2023
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 10/21/2021; 11/18/2021
• Initial Report FDA Received Date: 10/08/2021
• Supplement Report FDA Received Date: 11/12/2021; 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2021
• 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#-1544822.; FOAM TIP PLUNGER MODEL-FTP, LOT#-1527564.; INJECTOR MODEL-MSI-PF, LOT#-1528353.; UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female