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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Dry Eye(s) (1814)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On 23 dec 2020 we received notification of an article entitled, ' visual outcomes after sequential posterior chamber phakic iol with corneal refractive surgery (bioptics) for the treatment of myopic astigmatism.' the article references 3 eyes (2 patients) requiring punctual plugs due to dry eye with the visian icl.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

Corrected data: b5: on 23-12-2020, a notification of an article titled "visual outcomes after sequential posterior chamber phakic iol with corneal refractive surgery (bioptics) for the treatment of myopic astigmatism".The article notes a 100 eyes study and patients experienced dry eyes after pc-piol implantation; which 3 eyes of two patients required punctal plugs and also 6 eyes of three patients after laser ablation surgery also experienced dry eyes.It also mentions prk and lasik was performed on patient's in the study.The article conclusion indicates bioptics for high myopic astigmatism was safe and effective.Reverse bioptics although not tradition could provide similar results.Health effect impact code: 4625 - lasik/prk.Punctal plugs.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: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 11200457
• MDR Text Key: 227721197
• Report Number: 2023826-2021-00188
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

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: 12/23/2020
• Initial Date FDA Received: 01/20/2021
• Supplement Dates Manufacturer Received: 12/15/2021
• Supplement Dates FDA Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention