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

Device Problems Misfocusing (1401); Improper or Incorrect Procedure or Method (2017)

Patient Problems Cataract (1766); Intraocular Pressure Increased (1937); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

The reporter (patient current observing doctor) states that a surgeon at a different clinic implanted a implantable collamer lens of unknown model and size and power into the patients left eye (os) on (b)(6) 2022.The current observing doctor saw patient for the first time on (b)(6) 2022, where he unfortunately became aware of several medical errors.Per email the findings in the eye after the glaucoma attack were as follows-"temporal corneal incision, anterior chamber shallower, iris temporally depigmented and "ragged", pigment dispersion in the anterior chamber, wide and plegic pupil, icl speckled with pigment, anterior subcapsular lens opacity- cataract."teporal corneal incision, anterior chamber shallower, iris temporally depigmented and "ragged", pigment dispersion in the anterior chamber, wide and plegic pupil, icl speckled with pigment, anterior subcapsular lens opacity- cataract.Ocular background findings normal." attempts to obtain additional information from the implanting surgeon have not been successful.If additional information is received a supplemental medwatch report will be submitted.See mfr # 2023826-2023-00326 dor fellow eye (od).

Manufacturer Narrative

Clinical code 4581: temporal corneal incision, anterior chamber shallower, iris temporally depigmented and "ragged", pigment dispersion in the anterior chamber, wide and plegic pupil, icl speckled with pigment, anterior subcapsular lens opacity- cataract 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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 16301799
• MDR Text Key: 308822711
• Report Number: 2023826-2023-00386
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: LO
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/04/2023

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: 01/04/2023
• Initial Date FDA Received: 02/04/2023
• 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 Sex: Male