MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number SN60WF

Device Problems Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 12/16/2020

Event Type  Injury  

Manufacturer Narrative

The product has not been returned for analysis.Complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported, during cataract surgery with intraocular lens (iol) implant the surgeon verified tat the posterior capsule was intact.After insertion of the iol a "cut" was noted in the capsule that was inline with the leading haptic.She rotated the lens 90 degrees and felt that the capsule supported the lens adequately and ended the procedure.During the postoperative period it was noticed that the lens was starting to drift in the direction of the tear and no longer appeared stable.The patient was brought in for a lens exchange.Additional information is requested.

Event Description

Additional information received, one day following the initial treatment.The capsule no longer appeared stabled.(b)(6) days following the initial treatment, a lens exchange was performed.The surgeon reports, the patients prognosis is good, following the lens exchange.Additional information received, findings during the iol exchange (b)(6) week post implantation, included a clean edge break of the posterior capsule at the nasal equator without vitreous loss.After the case, the surgeon indented the cut and the explanted lens, when examining it with forceps under the microscope.The surgeon did not touch the leading haptic, which he felt ruptured the capsule, during his post op manipulation.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information provided in d.9, d.10, h.3, h.6, and h.10.The explanted was transported in a lens case in a large biohazard bag.Viscoelastic was dried on the lens.The lens had been cut into pieces.Only three pieces were returned (each full haptic and one large portion of optic).Both haptics are full and intact.The optic was scraped on the anterior edge near one haptic.Another area of the optic edge has torn/cut split damage.The optic had scratches.The lens was cleaned with lphse to further evaluate.There was no abnormalities to the shape of the haptics.Each haptic was evaluated microscopically inspecting the full length of both entire edges.There were no damaged areas or imperfections observed.The anterior and posterior surfaces were evaluated.No damaged areas were observed.Each haptic was pliable using tweezers to assess.Product history records were reviewed documentation indicated the product met release criteria.All listed associated products are qualified for use with this lens.The root cause cannot be determined for the reported event of "lens possibly causing capsule rupture".Three pieces of the explanted lens was returned.Both haptics were full and intact with no abnormalities to their shape.There was no damage observed to either haptic on their surfaces nor on their edges.The optic portion that was returned was damaged on the anterior surface and two areas of the edge.It is unknown if the one scraped edge area near the base of one haptic was interpreted as the complaint.The previous report submitted for this event contained an error in h.1.- ¿summary report¿ was inadvertently selected.After a recent systems update, a system error caused the inadvertent additional selection of ¿summary report¿ in h.1.On a select number of reports.The error, which was limited only to the h.1.Field, was promptly identified and quickly rectified.Correction smdrs are being filed for the impacted reports.This smdr is correcting that error for this event.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11160339
• MDR Text Key: 226539300
• Report Number: 1119421-2021-00080
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.180
• Device Lot Number: 15065840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH III D CARTRIDGES, 8065977763, HWV; MONARCH III IOL DELIVERY SYST, 8065977773, APD; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; UNSPECIFIED PROVISC
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR