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

Model Number	MICL12.6
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unk, unk, unk, unk, unk, date of event: unk.Work order search: no similar complaint type events were reported for units within the same lot.Claim # 431106.
Event or Problem Description
The reporter indicated that a 12.6mm, micl12.6, -16.0 diopter, implantable collamer lens was inserted upside down and when removing it, it tore.The lens was replaced with a backup lens within the same surgery.There was no patient injury.
Additional Manufacturer Narrative
H3- device evaluation : lens was returned in liquid, inside a vial.Visual inspection found one of the haptics torn.Claim# (b)(4).
Additional Manufacturer Narrative
Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 10571046
• Report Number: 2023826-2020-02260
• Device Sequence Number: 3033504
• Product Code: MTA
• UDI-Device Identifier: 00841542103367
• UDI-Public: 00841542103367
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/24/2020

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: 11/30/2021
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 09/28/2020; 04/06/2021
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 10/29/2020; 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR