MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ NATURAL SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number SN60WF

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/09/2020

Event Type  malfunction  

Manufacturer Narrative

The product was returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that during an intraocular lens (iol) implant procedure, the room was too cold, estimated to be below 16 degrees as the thermometer had not been working.The iol was loaded having heated the viscoelastic (with a hand) and the iol in the heating cabinet.The iol was stiff and did not move easily, so was thought not safe to proceed with insertion.A backup lens was loaded very quickly and insertion proceeded smoothly after a heating cabinet was used to bring the iol, viscoelastic and instruments up to room temperature.

Manufacturer Narrative

Product evaluation: the product was not returned for analysis.Additional information: the file states that "the temperature of the theatre was set at 14 degrees and was too cold".Root cause: while we are unable to determine the origin of the reported complaint, our observations reasonably suggest that it is not manufacturing related.Based on the information provided by the customer, the most likely root cause is failure to follow dfu, as the customer states that the temperature of the theatre was set at 14 degrees and was too cold.The dfu instructs that the iol and viscoelastic should be allowed to attain room temperature prior to use.The file states the use of a cartridge, dfu instructs that cartridge should be used at operating room temperatures between 18°c and 23°c.Not following the correct temperature may result in delivery issues and/or damage.All product and batch history records are quality reviewed prior to product release.Additional information provided in h.3., h.6.And h.10.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• MDR Report Key: 10352993
• MDR Text Key: 202519194
• Report Number: 9612169-2020-00166
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.215
• Device Lot Number: 21232328
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 07/31/2020
• Supplement Dates Manufacturer Received: 10/14/2020
• Supplement Dates FDA Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DUOVISC VIS SYSTEM; MONARCH III D CARTRIDGES; MONARCH III IOL DELIVERY SYST
• Patient Age: 58 YR