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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)

Patient Problems Cataract (1766); Glaucoma (1875); Pupillary Block (2026); Uveitis (2122); Halo (2227); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

An article was received from aao, 2009, for "phakic intraocular lens implantation for the correction of myopia".The article reported the following complications - endothelial cell loss, cataract formation, secondary glaucoma (pupillary block, pigment dispersion) iris atrophy (pupil ovalization), and traumatic dislocation.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

H6: health impact- clinical code: 4581 - endothelial cell loss; pigment dispersion; iris atrophy; lens dislocation.Claim #: (b)(4).

Manufacturer Narrative

Corrected data: b5: an article was received from aao 2009 for "phakic intraocular lens implantation for the correction of myopia".The article reported the following complications - elevated iop, lens opacity (cataract), glare/haloes, pigment dispersion, glaucoma, pupil block, lens dislocation (traumatic dislocation), loss of bcva, transient uveitis, endothelial cell loss, iris atrophy/pupil ovalization, unspecified reoperations (ssi).Additional information has been requested but none has been forthcoming.H6: health effect clinical code: 4581 - loss of bcva.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
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 17672769
• MDR Text Key: 322535679
• Report Number: 2023826-2023-03648
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/11/2023

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: 08/11/2023
• Initial Date FDA Received: 09/01/2023
• Supplement Dates Manufacturer Received: 12/17/2023
• Supplement Dates FDA Received: 12/17/2023
• 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
• Treatment: UNK.
• Patient Outcome(s): Other