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

Model Number	TMICL12.6
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight: unk.Race: unk.Ethnicity: unk.Implant date: unk.Explant date: unk.Claim # (b)(4).
Event or Problem Description
The reporter indicated a 12.6mm tmicl12.6 implantable collamer lens, -07.00/+2.0/095 (sphere/cylinder/axis), was scratched and it was unknown if there was any patient contact.The backup lens was implanted.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
B5: the back up lens was implanted and the problem was resolved.The cause of the event was unknown.Claim # (b)(4).
Additional Manufacturer Narrative
H3: device evaluation - lens was returned in vial with moisture.Visual inspection found optic and haptic torn.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 ; 6263037902
• MDR Report Key: 13002083
• Report Number: 2023826-2021-04804
• Device Sequence Number: 4216486
• Product Code: QCB
• UDI-Device Identifier: 00841542106443
• UDI-Public: 00841542106443
• 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
• 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): 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: TMICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 01/06/2022; 02/25/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 02/04/2022; 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2021
• 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 # 1492563; FOAM TIP PLUNGER MODEL FTP - LOT # 1471040; INJECTOR MODEL MSI-PF - LOT # UNK
• Patient Age: 34 YR
• Patient Sex: Female