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

Device Problem Unintended Movement (3026)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

A4: unk.A5: unk.A6: unk.B3: unk.D4: expiration date unk.D6a: unk.D6b: unk.H4: unk.H6: health impact- clinical code: 4581 - declining vision.H6: health impact - additional surgery: 4625 - femtosecond laser-assisted cataract surgery.Claim # (b)(4).

Event Description

A case report article was received regarding "femtosecond laser assisted cataract surgery in a complicated cataract patient with reverse implantable collamer lens: a case report".The patient was a 33-year-old female, who, 11 years ago, underwent bilateral posterior chamber phakic intraocular lens (piol) implantation due to myopia.The patient presented with a 2-year history of declining vision in right eye.The piol was found to have been inverted in the patients eye.The patient received femtosecond laser-assisted cataract surgery combined with piol extraction.Good visual results were achieved and there were no complications during the six-month follow-up.Additional information has been requested but none has been forthcoming.

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18632450
• MDR Text Key: 334445473
• Report Number: 2023826-2024-00282
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/16/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female