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

Model Number	VICM5_13.2
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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2: unk.A3: unk.A4: unk.A5: unk.A6: unk.B3: unk.D6a: unk.D6b: unk.H6 - work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 13.2mm vicm5_13.2 implantable collamer lens -11.50 diopter, into the patient`s left eye (os).The lens was explanted due to the surgeon noted a defect on the lens when it was implanted into the eye.The lens was replaced with another same model/length lens.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
H3: device evaluation: the lens was returned dry, in a plastic bag, with residue on product.Visual inspection found the lens optic and haptics torn.There was residue throughout the lens.(b)(4).
Additional Manufacturer Narrative
Corrected data: b1: product problem b5: the reporter indicated the surgeon inserted and removed a 13.2mm vicm5_13.2 implantable collamer lens, -11.50 diopter, within the same surgery due to the surgeon noted a defect on the lens when it was implanted into the patient's left eye (os).The lens was replaced with another same model/length lens.Additional information has been requested but none has been forthcoming.H1: malfunction h6: adverse event problem: health effect - impact code (f): 2199.H6: adverse event problem: medical device problem code: (a): 3189.Claim # (b)(4).
Additional Manufacturer Narrative
H6: device history record (dhr) review: the dhr review indicated that the product has been manufactured within the established process parameters and that there is no indication that the manufacturing and/or processing of the device contributed to the complaint issue.(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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 19217922
• Report Number: 2023826-2024-01997
• Device Sequence Number: 15207901
• Product Code: MTA
• UDI-Device Identifier: 00841542119443
• UDI-Public: 00841542119443
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/09/2024

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: 03/31/2025
• Device Model Number: VICM5_13.2
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 04/23/2024; 07/17/2024; 08/02/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 06/24/2024; 07/18/2024; 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown