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

Model Number EMERALDC30

Device Problems Break (1069); Inaccurate Delivery (2339); Mechanical Jam (2983)

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

Event Date 07/27/2021

Event Type  malfunction  

Manufacturer Narrative

Date implanted: not applicable, as the cartridge is not an implantable device.Date explanted: not applicable, as the cartridge is not an implantable device.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported the leading haptic of the intraocular lens (iol) was trapped in the emerald cartridge door and the haptic was bent backwards, and there was patient contact.Doctor suspected damage and changed for a new lens.Through follow-up, additional information was received confirming no unplanned incision enlargement, no serious patient injury, no unplanned suture(s), and no unplanned vitrectomy.The same procedure was completed using back-up lens with the same model and diopter size.It was confirmed the lens was not loaded incorrectly.No further information is available.

Manufacturer Narrative

Device evaluation: product evaluation could not be performed since, at the time of this investigation, the complaint product cartridge or iol had not been received; the lens case, patient stickers, and original folding carton were received for iol sn: 7575642105.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.There are no discrepancies found during the mrr (manufacturing record review) related to this complaint.Historical data analysis: a search of complaints revealed that one (01) additional complaint folder was found as part of this production order (po) number.Although the complaint issues reported are similar to the reported complaint issue, however the complaint was voided and therefore not confirmed.Conclusion: as a result of the investigation, there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.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 ; 1700 e. st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12435716
• MDR Text Key: 273871541
• Report Number: 2020664-2021-07144
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530027
• UDI-Public: (01)05050474530027(17)220309(10)CJ16470
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2022
• Device Model Number: EMERALDC30
• Device Catalogue Number: EMERALDC30
• Device Lot Number: CJ16470
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2021
• 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: ZA9003 IOL SN: (B)(6)
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White