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

Model Number	VTICM5 12.6
Medical Device Problem Code	No Apparent Adverse Event (3189)
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 an implantable collamer lens was implanted into the patient's left eye (os).Reportedly, "the patient has an unexptected hyperopic outcome.".
Additional Manufacturer Narrative
A4-a6:unk.B3: unk.D4 (experiation date); unk no serial number reported.D6a: unk.H4 (device manufacturing date): no serial number reported.Claim# (b)(4).
Additional Manufacturer Narrative
B5: the reporter indicated that the surgeon implanted a 12.6mm vitcm5_12.6 -10.50/1.0/177 (sphere/cylinder/axis) upside down into the patient's left eye (os) on (b)(6) 2023.The lens was exchanged on (b)(6) 2023 with a same length different diopter lens and problem was resolved.Reportedly "all resolved and patient has good outcome".Cause of event is user error; device did not fail to perform as intended.H6: investigation type 4110: lens work order search - no similar complaint event(s) within associated lots were found.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 muniz ; 800 royal oaks dr.; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 17839066
• Report Number: 2023826-2023-04235
• Device Sequence Number: 7409826
• Product Code: QCB
• UDI-Device Identifier: 00840311307838
• UDI-Public: 00840311307838
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2023

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: 02/28/2026
• Device Model Number: VTICM5 12.6
• 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: 09/15/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 12/13/2023
• Date Device Manufactured: 03/23/2023
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown