MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. SMARTLOAD; INTRAOCULAR LENS

Model Number GCB00

Device Problem Contamination (1120)

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

Event Date 11/24/2022

Event Type  malfunction  

Event Description

It was reported that foreign particles/ plastic pieces were introduced into the eye during implantation of the intraocular lens (iol).There was issue with the lens.Account indicated that there was no incision enlargement required, no vitrectomy, and no sutures.The iol remains implanted.The patient has recovered.No further information was provided.

Manufacturer Narrative

Per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Explant date: n/a, lens remains implanted.Initial reporter name and address: telephone number: (b)(6).Device evaluation: product testing could not be performed since the product was not returned for evaluation.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.A search of complaints related to this production order (po) was performed.The search revealed that no additional complaints were received for this po.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.Attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Additional information: section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: 28th december 2022.Section h3 - device evaluated by manufacturer? yes.Device evaluation: visual inspection under magnification revealed that the complaint smartload was received with the interior of the cartridge and lens module coated in an excessive amount of viscoelastic residue.No foreign materials could be identified and no damage inside of the smartload assembly could be identified as well.The complaint issue of dc-foreign material - loose was not confirmed.Therefore, there is no indication of a product deficiency or product malfunction.The reported issue is an anticipated/expected event for gcb00 (tecnis 1pc iol with smartload delivery technology) and does not represent a new risk.Based on the last annual risk management review and ongoing post market surveillance activities, the probability of occurrence for the reported event remains within the rates established in the risk management files.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: SMARTLOAD
• Type of Device: INTRAOCULAR LENS
• 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: 16000922
• MDR Text Key: 308238751
• Report Number: 3012236936-2022-03036
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P980040
• 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
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GCB00
• Device Catalogue Number: GCB0000190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2022
• 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