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

Model Number EMERALDC30

Device Problem Crack (1135)

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

Event Date 04/01/2021

Event Type  malfunction  

Manufacturer Narrative

Age or date of birth, weight, ethnicity: information unknown/not provided.Date of event: the exact date of event is unknown, not provided, but the best estimate date is (b)(6) 2021.Implant date: if implanted, give date: n/a (not applicable).The cartridge is not an implantable device.Explant date: if explanted, give date: n/a (not applicable).The cartridge is not an implantable device; therefore, not explanted.Phone number: (b)(6).Device evaluation: the emeraldc30 cartridge was not returned in its original package.Visual inspection using magnification was performed to the returned sample which residues of viscoelastic material was observed on the cartridge.The cartridge tip was observed deformed.Based on the sample evaluation, there is no evidence to suggest that the complaint unit has been affected by the manufacturing process.The condition in which the sample returned is consistent with a product that was handled and prepare for surgical process.The complaint issue reported was verified.Manufacturing record evaluation: the manufacturing process record was evaluated, and no discrepancies were found during the mrr (manufacturing record review) related to this complaint issue reported.The product was manufactured and released according to specifications.A search in complaint system revealed that no additional complaints were received for this production order number.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that an intraocular lens was set to be implanted during an operation that was successfully completed without a problem with implantation.But the tip of the cartridge was found to be damaged (it got a bit turned over) when the lens was inserted.There was no patient injury reported.No further information was provided.

• 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 ; road 402 north, anasco ind. pk; anasco, PR 00610 ; 7142478552
• MDR Report Key: 11751218
• MDR Text Key: 248148235
• Report Number: 2648035-2021-07722
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)210930(10)CH14767
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2021

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: 09/30/2021
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CH14767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/01/2021
• Initial Date FDA Received: 04/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2020
• 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