MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. UNFOLDER EMERALD; LENS, GUIDE, INTRAOCULAR

Model Number EMERALDC30

Device Problems Contamination (1120); Material Opacification (1426); Scratched Material (3020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Per eu regulation 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Date of event: unknown/no information.If implanted, give date: not applicable.The cartridge is not an implantable device.If explanted, give date: not applicable.The cartridge is not an implantable device; therefore, not explanted.(b)(6).The device has not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that an intraocular lens (iol) implanted in a 45-year-old female patient's eye was "extremely scratched".Further follow-ups revealed that the cartridge caused the scratches during the loading process while preparing the lens for implantation.No further information was provided.

Manufacturer Narrative

Additional information: section h6 - medical device problem code: 1120.The doctor started to observe the phenomena around 4 months prior, without any impact to the patients¿ health.Subject matter experts assessed the photos and the observations could potentially be caused by glycerol monostearate (gms) residues on the lens surface instead of lens scratches.Gms is used as lubricant in the inserter at manufacturing to facilitate the intraocular lens moving through the system.According to the doctor, the cartridges are stored at about 20 degrees celsius.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data section h6: contamination code removed.While the observations that the customer experienced is potentially compatible with glycerol monostearate (gms) residues on the lens surface instead of lens scratches, this has not been confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data: upon further review, it was determined that medical device problem code inclusions-1426 would be the more appropriate code.The following section has been updated accordingly: medical device problem code: was corrected to 1426 - material opacification.The code provided in the initial report code 3020 is no longer applicable.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: UNFOLDER EMERALD
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 13510422
• MDR Text Key: 296305986
• Report Number: 3012236936-2022-00340
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)220727(10)CJ26367
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2022
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CJ26367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2021
• 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
• Treatment: AR40E LENS, LOT UNKNOWN
• Patient Age: 45 YR
• Patient Sex: Female