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

Model Number EMERALDC30

Device Problems Material Fragmentation (1261); Device Difficult to Setup or Prepare (1487); Material Split, Cut or Torn (4008)

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

Event Date 06/17/2021

Event Type  malfunction  

Manufacturer Narrative

Pt info: unknown/not provided.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.Telephone number: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

Event Description

Customer reported that during the handling of the emerald cartridge, inserting methylcellulose and position the intraocular lens (iol), the cartridge was presenting rigidity while the iol was being inserted in the eye.Resulting in a torn optical part and the haptic was completely amputated.There was no reported patient impact.No additional provided.

Manufacturer Narrative

Device evaluation: product testing could not be performed since at the time of this investigation, the product has not been received for evaluation.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed one complaint found as part of this lot number and is coded for ¿cartridge damaged¿ which is a similar code of the one used in this investigation.There was no product received; therefore, no product malfunction or deficiency could be identified, and no escalations are required.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: EMERALD CARTRIDGE
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 12200799
• MDR Text Key: 262693677
• Report Number: 2648035-2021-08183
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)220301(10)CJ15429
• Combination Product (y/n): N
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2022
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CJ15429
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IOL SERIAL# AND MODEL UNKNOWN; IOL SERIAL# AND MODEL UNKNOWN