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

Model Number	MICL 13.2
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Work order search: no similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted upside down a 13.2mm micl13.2, -16.0 diopter, implantable collamer lens, into the patient's left eye (os).Reportedly, "surgeon believes lens inserted upside down, will be replaced with another lens." additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Additional information: b5 - the reporter indicated that the surgeon implanted upside down a 13.2mm micl13.2, -16.0 diopter, implantable collamer lens, into the patient's right eye on (b)(6) 2021.There was patient contact (lens touched the eye) with no patient injury.The lens was exchanged on (b)(6) 2020, with a same size lens due to trans lent loss of bcva and low vault.The problem was resolved.Cause of the event is reported as user error, "upside down lens was not recognized until post op evaluation." reportedly, "vision improved 1 line better than preop best corrected." claim# (b)(4).
Additional Manufacturer Narrative
B5: the reporter indicated that the surgeon implanted upside down a 13.2mm micl13.2 implantable collamer lens of -16.0 diopter into the patient's right eye (od) on (b)(6) 2021.There was patient contact (lens touched the eye) with no patient injury.Transient loss of bcva and low vault were observed.The lens was exchanged on (b)(6) 2021 for a shorter length lens which resolved the problem.Cause of the event is reported as user error, "upside down lens was not recognized until post op evaluation." reportedly, "vision improved 1 line better than preop best corrected." 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: 11273781
• Report Number: 2023826-2021-00235
• Device Sequence Number: 3532854
• Product Code: MTA
• UDI-Device Identifier: 00841542103411
• UDI-Public: 00841542103411
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2021

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: 07/31/2021
• Device Model Number: MICL 13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 02/08/2021; 08/31/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 02/10/2021; 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 21 YR