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

Model Number	MICL13.2
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	Corneal Edema (1791)
Date of Event	01/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem 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.".
Additional Manufacturer Narrative
(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: 8339700
• Report Number: 2023826-2019-00259
• Device Sequence Number: 10798050
• Product Code: MTA
• UDI-Device Identifier: 00841542103213
• UDI-Public: 00841542103213
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2019

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?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 09/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other