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

Model Number MICL13.2

Device Problems Inadequacy of Device Shape and/or Size (1583); Appropriate Term/Code Not Available (3191)

Patient Problems Corneal Edema (1791); Headache (1880); Intraocular Pressure Increased (1937); Nausea (1970); Pain (1994); Vomiting (2144)

Event Date 05/06/2014

Event Type  Injury  

Event Description

The reporter indicated the surgeon implanted a 13.2mm micl13.2 implantable collamer lens in the patient's left eye (os) on (b)(6) 2014.At the same day post-op examination, the intraocular pressure was slightly elevated and the icl had a 200% vault.The patient was comfortable and uncorrected visual acuity was 20/40.The patient was sent home.Later that same evening, the patient complained of severe pain, nausea, vomiting and extreme headache.Patient returned to surgeon's office where intraocular pressure was high, increased corneal edema and shallow anterior chamber.The iridotomies appeared patent, but lpi enhancement was necessary to lower pressures."burping" of the wound was performed and the intraocular pressure was lowered to satisfactory levels.Patient was given istalol, alphagan and diamox to take home.The patient returned on (b)(6) 2014, the visual acuity uncorrected was 20/70, intraocular pressure was 11, cornea showed 1+ edema and anterior chamber was shallow with lens having a 200%+ vault.The surgeon determined the lens was too large and felt lens exchange for a smaller lens was necessary.The lens was explanted on (b)(6) 2014 and a shorter lens was implanted.Same day post-op revealed intraocular pressure to be 16, visual acuity uncorrected was 20/40 with 1+ corneal edema and 100% vaulting of lens.At post-op visit on (b)(6) 2014, visual acuity uncorrected was 20/15, intraocular pressure was 13 with clear cornea and lens had 100% vault.Patient is happy.The reporter indicated a possible cause of the event was lens sizing.

Manufacturer Narrative

(b)(4) - intraocular pressure, rise; corneal edema; pain; nausea; headache; vomiting.Size incorrect for patient; (vaulting).Evaluation method: work order search.Results: a lens work order search was performed and no similar complaints were found within the work order.Visual inspection of the returned product found a piece of one haptic torn off and missing.The lens was returned in liquid.Conclusions - (no conclusion can be drawn): based on the complaint history, work order search and the evaluation of the returned product, a specific root cause of the event could not be determined.(b)(4).

Manufacturer Narrative

Method: medical review.Results: per medical review - reportedly icl was explanted/exchanged for a different lens length, two days postoperatively, to address excessive lens vaulting and subsequent complications (elevated iop, corneal edema).Before lens exchange patient was medically treated out of standard regimen.At one week follow-up ((b)(6) 2014), after implantation of a different length icl, patient status improved and patient was very happy (uva 20/15).According to the report from the facility the most likely cause of the reported event was procedure related factor (ordering of an oversized length).It should be noted that placement of an oversized icl is well described in the literature as a potential cause of lens vaulting and undesired patient outcome and complications.The dfu instructs physicians under "surgical precautions/information about visian icl length determination" how to perform pre-op measurements and choose a proper icl by providing a table of recommended visian icl overall diameter.Conclusions: based on the complaint history, work order search, medical review and the evaluation of the returned product, the most likely cause of the reported event was procedure related factor (ordering of an oversized length).(b)(4).

Manufacturer Narrative

Method: (process evaluation): device history record review.Result: (operational problem) : based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within the established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Conclusion: (unable to confirm complaint): based on the complaint history, work order search, device history record review, medical review, and product evaluation, a specific root cause of the event could not be determined.(b)(4).

• Brand Name: VISIAN ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; haupstrasse 104; nidau, CH-25 60; SZ CH-2560
• Manufacturer (Section G): STAAR SURGICAL COMPANY; haupstrasse 104; nidau, CH-25 60; SZ CH-2560
• Manufacturer Contact: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 3942601
• MDR Text Key: 4641615
• Report Number: 2023826-2014-00491
• 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,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 06/19/2014

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: Physician
• Device Expiration Date: 09/30/2015
• Device Model Number: MICL13.2
• Other Device ID Number: DIOPTER -11.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2014
• Initial Date FDA Received: 07/17/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/26/2014; 06/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2013
• 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 Age: 20 YR