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

Model Number MICL 13.2

Device Problems Improper or Incorrect Procedure or Method (2017); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2021

Event Type  Injury  

Manufacturer Narrative

Work order search: no similar complaint type events were reported for units within the same lot.(b)(4).

Event 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.

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).

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)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 11273781
• MDR Text Key: 230215449
• Report Number: 2023826-2021-00235
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103411
• UDI-Public: 00841542103411
• Combination Product (y/n): N
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 02/08/2021; 08/31/2021
• Supplement Dates FDA Received: 02/10/2021; 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR