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

Model Number	VTICM512.6
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a surgeon implanted a 12.6mm vticm512.6 implantable collamer lens of a -13.5/2.0/088 (sphere/cylinder/axis) was implanted upside down, and tore while explanting.The backup lens was then implanted.
Additional Manufacturer Narrative
Patient identifier, age or date of birth, sex, weight, ethnicity, race: unk.Work order search found no similar complaints within associated lots.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: g2: report source: foreign should be ommitted for correction.H3: device evaluated by manufacturer- no should be selected for correction.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: h1: type of reporable event-malfunction should be ommitted and serious injury should be selected for correction.H6: health effect: impact code: 4627 should be added for device explantation.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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 15697662
• Report Number: 2023826-2022-03890
• Device Sequence Number: 20509835
• Product Code: QCB
• UDI-Device Identifier: 00841542115476
• UDI-Public: 00841542115476
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2022

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: 12/31/2023
• Device Model Number: VTICM512.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2022
• Supplement Date Received by Manufacturer: 12/18/2022; 01/04/2023
• Initial Report FDA Received Date: 10/30/2022
• Supplement Report FDA Received Date: 01/03/2023; 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2022
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown