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

Model Number	VICM5_13.2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated the surgeon inserted and removed a 13.2mm vicm5_13.2 implantable collamer lens, -10.50 diopter, within the same surgery due to the lens was torn before loading.The reporter indicated the lens was received with a small tear.As the lens was being injected into the anterior chamber, the lens came out from the injector already broken.The cause of the event was unknown.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
Patient weight: unk.Patient ethnicity: unk.Patient race: unk.Work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).
Additional Manufacturer Narrative
H3: device evaluation: the lens was returned dry, in a microcentrifuge vial, with residue/debris on product.Visual inspection found the haptic torn.There was debris throughout the lens.Claim # (b)(4).
Additional Manufacturer Narrative
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 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: 16595141
• Report Number: 2023826-2023-00953
• Device Sequence Number: 13861864
• Product Code: MTA
• UDI-Device Identifier: 00840311300945
• UDI-Public: 00840311300945
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Model Number: VICM5_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: 02/23/2023
• Supplement Date Received by Manufacturer: 05/31/2023; 07/03/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 06/27/2023; 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2022
• 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.
• Patient Age: 41 YR
• Patient Sex: Female