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

Model Number	TMICL13.2
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lens work order search-no similar complaint type events reported for units within the same lot.Claim# (b)(4).
Event or Problem Description
The reporter states a 13.2mm tmicl13.2 implantable collamer lens -7.0/+2.5/171 (sphere/cylinder/axis) was "vold to flat, remove." attempts to obtain additional information have not been successful.
Additional Manufacturer Narrative
H3-device evaluation: the lens was returned in liquid in a vial and biohazard bag.Visual inspection found no visible damage to the lens.Claim#: (b)(4).
Additional Manufacturer Narrative
B5-additional info: on (b)(6) 2021 the lens was explanted due to low vault.The cause is reported as device and a patient-related factor.Reportedly, the patient had high anxiety due to low vault and was unwilling to wait for more healing and requested the icl be explanted.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
• MDR Report Key: 11823314
• Report Number: 2023826-2021-01445
• Device Sequence Number: 3721924
• Product Code: QCB
• UDI-Device Identifier: 00841542108621
• UDI-Public: 00841542108621
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2021

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: 10/31/2022
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 05/25/2021; 06/18/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 06/17/2021; 07/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL-SFC-45, LOT#-1518547; FOAM TIP PLUNGER MODEL-FTP, LOT#-1509330; INJECTOR MODEL-MSI-PF, LOT#-UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR