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

Model Number MICL13.7

Device Problems Off-Label Use (1494); No Apparent Adverse Event (3189)

Patient Problem No Patient Involvement (2645)

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

No similar complaint was reported for units within the same lot.(b)(4).

Event Description

The reporter indicated the surgeon was loading a 13.7mm micl13.7 implantable collamer lens, -16.00 diopter, and noted a nick in the lens.There was no patient contact and the backup lens was implanted.The problem was resolved and the patient is doing well.The cause of the event was unknown.

Manufacturer Narrative

H3: device evaluation: the lens was returned in liquid in lens vial.Visual inspection found the lens haptic torn.H6 - device code: 1494 - this lens model is contraindicated for patients with age less than that of 21 years.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
• MDR Report Key: 10356711
• MDR Text Key: 202383514
• Report Number: 2023826-2020-01607
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103688
• UDI-Public: 00841542103688
• Combination Product (y/n): N
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/17/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: MICL13.7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 08/03/2020
• Supplement Dates Manufacturer Received: 08/18/2020
• Supplement Dates FDA Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 19 YR