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

Model Number	MICL12.6
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age or date of birth: unk.Sex: unk.Weight: unk.Ethnicity: unk.Race: unk.Date of event: unk.Work order search: no similar complaint was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated a 12.6mm micl12.6 implantable collamer lens, -11.50 diopter, was opened and not used, with no patient contact.The lens was returned to the manufacturer and was found to be damaged.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
H3: device evaluation: the lens was returned in liquid, in microcentrifuge vial.Visual inspection found one haptic torn.Claim # (b)(4).
Additional Manufacturer Narrative
Additional data: b5: the reporter indicated the cause of the event was due to user error.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
• MDR Report Key: 11556798
• Report Number: 2023826-2021-00738
• Device Sequence Number: 17194615
• Product Code: MTA
• UDI-Device Identifier: 00841542103053
• UDI-Public: 00841542103053
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2021

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: 09/30/2022
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 03/15/2021; 05/14/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 05/05/2021; 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1