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

Model Number MICL13.2

Device Problem Difficult to Fold, Unfold or Collapse (1254)

Patient Problem Corneal Edema (1791)

Event Date 01/16/2019

Event Type  Injury  

Manufacturer Narrative

No similar complaint type events were reported for units within the same lot.(b)(4).

Event Description

The surgeon reported that he attempted to implant a 13.2mm, micl13.2, -6.0 diopter, implantable collamer lens into the patient's eye but it would not unfold." i never completed the insertion into the eye because the lens would not unfold about 65% out of the injector and i felt it not prudent to proceed given the 3 attempts to allow it to unfold.The lens was never fully implanted, the lens was allowed to come out of the injector about 60-70% and allowed to unfold but it never did.I used maneuvers such as "jiggling" the injector.I removed the injector each time, reloaded, and inserted 2 additional times.No lasting injury to the patient.Just more corneal edema than usual, but it resolved as expected.Cause of corneal edema is unclear, likely surgery but given the fact that the product made the surgery more complicated than necessary, could be product as well, but not directly.No, corneal edema did not require treatment beyond what is standard after ocular surgery.".

Manufacturer Narrative

(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: 8339700
• MDR Text Key: 136160453
• Report Number: 2023826-2019-00259
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103213
• UDI-Public: 00841542103213
• Combination Product (y/n): N
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: MICL13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Date Manufacturer Received: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other