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

Model Number VICMO13.2

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

Patient Problems Endophthalmitis (1835); Hypopyon (1913); Inflammation (1932); Intraocular Pressure Increased (1937); Pain (1994); Red Eye(s) (2038); Blurred Vision (2137); Vitritis (2181); No Code Available (3191)

Event Date 08/08/2018

Event Type  Injury  

Manufacturer Narrative

This product is not marketed in the us.(b)(4).

Event Description

The reporter indicated that a 13.2mm vicmo13.2, -13.0 diopter, implantable collamer lens was implanted on (b)(6) 2018 and observed to have intraocular inflammation and vitritis 1 day post-op.Upon examination, the surgeon " found reaction and membranes in ac" and "was obligated to keep patient inside the hospital".The patient "undergoes intra-vitreal antibiotic injection" and " the doctor is worried about endophthalmitis".Per (b)(6) 2018 email from reporter, the surgeon has explanted the lens.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

(b)(4)."no similar complaint type events were reported for units within the same lot" not included in the initial mdr.(b)(4).

Manufacturer Narrative

Additional information was received on 11 dec 2018.The culture is (b)(6).Patient is stable now and the problem is resolved after intravitreal injection.(b)(4).

Manufacturer Narrative

Additional information event- additional information was received on (b)(6)2018: "female patient seeking refractive surgery rt uneventful icl implantation was done routine post operative ttt vigamox ed 1×5 econopred ed 1×5 2nd day post operative the patient presented with diminution of vision, pain and red eye.By exam ciliary injection, hypopyon in ac, high iop 32, pupillary membrane.Fundus not seen.Admission of the patient u/s was free.Treat as tass frequent topical steroids, hourly topical antibiotics, cycloplic, topical antiglaucoma.By the end of the day no improvement except the iop decreased u/s showed vitritis intravitreal vanco and ceftazidime 1mg was given 2nd day the hypopyon increased and no improvment ac wash was done but the membranes were behind icl so i decided to explant the icl and peeling the membranes in front of the crystalline lens but the yellow reflex was still present a vitroretinal colleague started to put ppv set examined the posterior segment.We found dense intravitreal membranes; vitreous sample with the aqueous sample was taken and sent to microbiologists.Ppv was done and intravitreal vanco and ceftazidime was given at the end of the surgery.The patient improved 2nd post operative after 1 week she regained her preop bcva." event- additoinal information received on 30 nov 2018 from reporter: a 13.2mm vicmo13.2, -13.0 diopter, implantable collamer lens was implanted into the patients right eye (od) on (b)(6)2018.On (b)(6)2018 the lens was explanted due to observation of elevated intraocular pressure (without pupil block and angle closure), suspected endophtalmitis and inflammation.Medical intervention (intraocular injection) was reported.Patients condition at last visit date: (b)(6)2018, recovered post operative bcva.The following was reported as additional information in complaint form: " it is indicated that its a case of tass with hypopyon in ac and pupillary membranes, intravitreal membranes was also found and case improved after ppv with intravitreal vancomycin and ceftazidime injection.Patient code:(b)(4).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
• MDR Report Key: 7853704
• MDR Text Key: 119482463
• Report Number: 2023826-2018-01352
• 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: distributor,health profession
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/08/2018

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
• Device Expiration Date: 03/31/2019
• Device Model Number: VICMO13.2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/08/2018
• Initial Date FDA Received: 09/06/2018
• Supplement Dates Manufacturer Received: 11/07/2018; 12/11/2018; 01/15/2019
• Supplement Dates FDA Received: 12/03/2018; 01/11/2019; 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR