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

Model Number	VTICM5_13.2
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); 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	09/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4-a6:unk.B3: unk.D4 (expiriation date); unk no serial number reported.D6a: unk.H4 (device manufacturing date): no serial number reported.Claim# (b)(4).
Event or Problem Description
The reporter indicated that an implantable collamer lens was implanted into the patient's left eye (os).Excessive vault was observed.
Additional Manufacturer Narrative
B5: lens was exchanged.Claim# (b)(4).
Additional Manufacturer Narrative
Additional data: b5- the reporter indicated that the surgeon implanted a 13.2mm vticm513.2 implantable collamer lens of diopter -8.50/1.0/088(sphere/cylinder/axis) into the patient's left eye (os) on (b)(6) 2022.The patient experienced excessive vault.On (b)(6) 2023 the lens was explanted.On the same day separate surgery the lens was replaced with the same model, shorter length lens and the problem was resolved.The cause of the event is unknown.H6- type of investigation code: 4110- lens work order search-no similar complaint event(s) within associated lots were found.Claim# (b)(4).
Additional Manufacturer Narrative
B5- the reporter indicated that the surgeon implanted an implantable collamer lens into the patient's left eye (os).The patient experienced excessive vault.Reportedly " exchanging lens because of overvaulting".On (b)(6) 2023 the lens was explanted and replaced.H6-health effect- impact code: "4629" should be removed and code "4627" should be added.H6- medical device code: "3189" should be removed and "2993" should be added.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC 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: 17777896
• Report Number: 2023826-2023-04087
• Device Sequence Number: 6551449
• Product Code: MTA
• UDI-Device Identifier: 00841542116367
• UDI-Public: 00841542116367
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 09/05/2023

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: 04/30/2024
• Device Model Number: VTICM5_13.2
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/20/2023; 10/30/2023; 12/22/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 09/20/2023; 10/30/2023; 12/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• 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 Age: 31 YR
• Patient Sex: Female