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

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923)

Patient Problems Cataract (1766); Corneal Edema (1791); Retinal Detachment (2047); Blurred Vision (2137); Capsular Bag Tear (2639); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Age: unk.Sex: unk.Weight: unk.Race: unk.Date of event: unk.Expiration date: unk.Implant date: unk.Explant date: unk.This product is manufactured in the u.S.But not marketed in the u.S.Mfr date: unk.(b)(4).

Event Description

An article was received that cited a case study of 87 eyes of 55 myopic patients, who underwent bilensectomy (phakic intraocular lens piol - explantation with cataract surgery and iol implantation), for posterior chamber piol, with a follow up time of 12 months.The main reason for bilensectomy was cataract development, followed by miscalculation of lens size and corneal edema.Intraoperative complications were one posterior capsule rupture and 3 eyes required use of pupil expanders for adequate pupil dilation.Postoperatively, one eye developed retinal detachment.Good safety and visual outcomes were observed 1 year after bilensectomy.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.

Manufacturer Narrative

B5 - corrected to "an article was received that cited a case study of 87 eyes of 55 myopic patients, who underwent bilensectomy (phakic intraocular lens piol - explanation with cataract surgery and iol implantation), for posterior chamber piol, with a follow up time of 12 months.The main cause of bilensectomy was due to cataract development, corneal edema, iol dislocation, refractive surprise.Intraoperative complications were one posterior capsule rupture and 3 eyes required use of pupil expanders for adequate pupil dilation.Postoperatively, there was one case of hydro reactive mydriatic pupil requiring pupilloplasty , retinal detachment, and posterior capsule opacification, and two cases of pigment over the trabecular meshwork and high iop requiring a combined procedure with trabeculectomy.Good safety and visual outcomes were observed 1 year after bilensectomy.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted." in initial mdr.H6 - patient code: 2137 - refractive surprise should be added in initial mdr.H6 - device code: 2923 - lens dislocation should be added in initial mdr.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
• MDR Report Key: 10356766
• MDR Text Key: 209564748
• Report Number: 2023826-2020-01609
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 07/08/2020

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
• Initial Date Manufacturer Received: 07/08/2020
• Initial Date FDA Received: 08/03/2020
• Supplement Dates Manufacturer Received: 04/05/2021
• Supplement Dates FDA Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention