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

Model Number MICL13.7

Device Problem No Apparent Adverse Event (3189)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A 13.7mm micl13.7 implantable collamer lens, -16.00 diopter, was returned to the manufacturer damaged.It was reported the lens tore at the haptic.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.

Manufacturer Narrative

B5: the reporter indicated the lens tore during folding.H3: device evaluation: the lens was returned in liquid, in a micro-centrifuge vial.Visual inspection found the haptic torn.Claim # (b)(4).

Manufacturer Narrative

Corrected data: h6 - work order search: another similar complaint was reported for units within the same lot.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: 11099004
• MDR Text Key: 224792314
• Report Number: 2023826-2020-03211
• 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,Followup
• Report Date: 12/01/2020

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: 11/09/2020
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 01/04/2021; 03/25/2021
• Supplement Dates FDA Received: 01/27/2021; 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1