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

Model Number	TMICL13.7
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight, ethnicity, race: unk.No similar complaint type events were reported for units within the same lot.Claim #(b)(4).
Event or Problem Description
The reporter indicated that a 13.7mm, tmicl13.7, -15.00/1.5/141 (sphere/cylinder/axis), implantable collamer lens was implanted and removed because it got stuck to plunger and doctor felt it might have damaged it.No patient injury.Used backup.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
The reporter indicate that the a 13.7mm, tmicl13.7, -15.00/1.5/141 (sphere/cylinder/axis), implantable collamer lens was implanted, removed and replaced within the same surgery due to lens stuck in cartridge or injection system.There was no patient injury and problem resolved.In the reporter's opinion the device was the cause of the event, for cause details the reporter stated "lens did not release from plunger".H6- health effect- impact code: 4627 to 2199- previous code not applicable, patient did not require a corrective procedure to remove lens.H6- medical device problem code: 2993 to 3189- previous code not applicable, no adverse event occurred.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 ; 8002927902
• MDR Report Key: 12029356
• Report Number: 2023826-2021-01922
• Device Sequence Number: 17228132
• Product Code: QCB
• UDI-Device Identifier: 00841542111898
• UDI-Public: 00841542111898
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: TMICL13.7
• 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: 05/19/2021
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2023
• 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 W.FTP, LOT # UNK.; UNK.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 34 YR
• Patient Sex: Male