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

Pt info: information unknown/not provided.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/not provided.If implanted, give date: n/a (not applicable).The cartridge is not an implantable device.If explanted, give date: n/a (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 all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that there were scratch marks on the intraocular lenses (iols) after implantation.The issues were first identified during the follow-up examinations.There were no medical interventions reported.Through follow-up, the surgeon clarified there were lathe lines in the ar40 lenses.The surgeon noticed these over the past two months.One of the products was an ar40 28.0 diopter, and he had noticed the lathe lines in other patients.The surgeon had sent pictures of the lens that he pushed through the injector quasi in vitro and then photographed it.The surgeon reported using methocel along with the standard injector to inject the lenses.The lenses remain implanted in the patients operative eyes.There are no visual acuity issues.There are no medical or surgical intervention planned and the patients have no restrictions.Through further follow-up, it was learned that the customer uses the emeraldc cartridge.The surgeon reported the issue has occurred for all ar40 lenses that they have installed in the last two months.The surgeon reported the patients tend not to notice the issue, as they just tolerate the lens pits and multifocal lenses.The surgeries were standard.The expected outcome is not perfectly clear lenses.The surgeon has alleged that the cartridges could have contributed to the scratches.The photos provided were evaluated by a subject matter expert and it was determined the images were consistent with scratches on the lens possibly caused by the cartridges.No further information was available.This report is for #1 of the 2 reported events (unknown number of patients).A separate report is being submitted for the cartridge with ar40 28.0 diopter.

Manufacturer Narrative

Additional information: section h6 contamination.A subject matter expert spoke with the doctor to discuss his recently communicated observations.The doctor disclosed that he started to observe the phenomena around 4 months ago, to date without any impact to the patients¿ health.The subject matter expert communicated to him that based on the discussion with the product (emerald inserters) subject matter experts, per their photo assessment, the observations are potentially compatible with 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 passing of the intraocular lens 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: md-0008095 inadvertently mentioned a photo assessment, however the photo assessment was associated with another report, and was included in this report in error.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data section h6: contamination code was 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.This report submitted to correct code previously reported.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data: section h6: the medical device problem code was corrected to 1426 - material opacification.Based on further review of the reported issue it was determined that this is the more appropriate code.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: 13516467
• MDR Text Key: 296225654
• Report Number: 3012236936-2022-00342
• 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,Followup
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• 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, SN UNKNOWN