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

Model Number	VTICM5 13.2
Medical Device Problem Code	Misfocusing (1401)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	07/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Claim # (b)(4).
Event or Problem Description
It was reported that an implantable collamer lens was implanted into the patients left eye (os) and refractive surprise was observed.Lens remains implanted.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
B5: lens explanted on (b)(6) 2023 and replaced the same day with same length different diopter lens.Problem resolved.Status of eye "all fine! patient is happy! subj refraction: -1.50dpt." h6: investigation type 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 a 13.2mm vticm5_13.2 -5.0/1.0/003 (sphere/cylinder/axis) was implanted into the patient's left eye (os) on (b)(6) 2023.Refractive surprise was observed.Lens remains implanted.Cause of the event is marked as unknown.Claim# (b)(4).
Additional Manufacturer Narrative
H3: device evaluation - lens was returned in microcentrifuge vial dry.Visual inspection found no visible damage to lens.Dimensional inspection found the lens to be within specification.Functional inspection found that the returned lens did not meet original values measured at the time of manufacturing.H6: device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device; have been manufactured within established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.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 ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 17552477
• Report Number: 2023826-2023-03524
• Device Sequence Number: 6863680
• Product Code: QCB
• UDI-Device Identifier: 00840311311088
• UDI-Public: 00840311311088
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P030016
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/19/2023

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: 11/30/2025
• Device Model Number: VTICM5 13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 08/18/2023; 11/22/2023; 01/26/2024
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 09/13/2023; 12/14/2023; 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown