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

Model Number	VTICM5_12.6
Medical Device Problem Codes	Misfocusing (1401); Off-Label Use (1494); Optical Problem (3001)
Health Effect - Clinical Codes	Cataract (1766); Blurred Vision (2137); Visual Disturbances (2140); Halo (2227); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: health impact- clinical code: 4581 - pigment dispersion, chafing of iris, iris transillumination, mydriasis.H6 - device code: 1494 - this lens model is contraindicated for patients with an anterior chamber depth (acd) less than 3.0mm.H6 - work order search: no similar complaint was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 12.6mm vticm5_12.6 implantable collamer lens, -10.50/+1.5/088 (sphere/cylinder/axis), into the patients left eye (os) on (b)(6) 2022.The lens was removed on (b)(6) 2023 due to lens opacity (cataract, anterior subcapsular) was observed on (b)(6) 2022.There was pigment dispersion and the patient complained of blurred vision and glare/haloes.The problem was resolved.Chafing of iris with resulting significant iris transillumination between 1 week and 1 month post op with slow progression; despite excellent vault.Believed to be mechanical issue related to lens/iris approximation.The post-op status of the eye after lens removal was stable iris transillumination.Anisocoria improved but still with mydriasis and ovoid pupil.
Additional Manufacturer Narrative
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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 16904423
• Report Number: 2023826-2023-01686
• Device Sequence Number: 20542323
• Product Code: QCB
• UDI-Device Identifier: 00841542115049
• UDI-Public: 00841542115049
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• 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: 04/12/2023
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2022
• 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 Age: 34 YR
• Patient Sex: Female