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

Model Number PSCST30

Device Problems Crack (1135); Use of Device Problem (1670)

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

Event Date 12/20/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: the product was returned to the manufacturing site for evaluation. Visual inspection under magnification revealed that the cartridge was received with a crack that ran from the tube of the cartridge to the tip. The cartridge presented with no further issues. Manufacturing record review: the manufacturing records for the intraocular lens were reviewed. The product was manufactured and released according to specification. The search revealed one additional investigation request (ir) for this production order number has been received, however, complaint was not confirmed based on the investigation. Based on the complaint history review results, no escalation was required. 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 & johnson surgical vision, inc. Has been submitted.

Event Description

It was reported that the intraocular lens (iol) had loading issue and the cartridge broke. There was contact with patient's right eye and the lens was removed and replaced in the same procedure. The procedure was completed using another lens of same model and diopter. The event was observed while inserting into the eye. No further information was available.

• Brand Name: UNFOLDER SILVER
• 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: 14257263
• MDR Text Key: 290447178
• Report Number: 3012236936-2022-00970
• Device Sequence Number: 1
• Product Code: KYB
• 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,Distributor

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/19/2022
• Device Model Number: PSCST30
• Device Catalogue Number: PSCST30
• Device Lot Number: CJ21692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/29/2022 Patient Sequence Number: 1

Treatment

Z9002 SN:(B)(4)