MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. UNFOLDER PLATINUM 1 SERIES; LENS, GUIDE, INTRAOCULAR

Model Number 1MTEC30

Device Problems Crack (1135); Mechanical Problem (1384); Mechanical Jam (2983)

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

Event Date 02/09/2021

Event Type  malfunction  

Manufacturer Narrative

Weight and ethnicity: unknown, information not provided.If implanted, give date: not applicable as this is not an implantable device. if explanted, give date: not applicable as this is not an implantable device.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that tip of 1mtec30 cracked/deformed, lens did not advance in cartridge and plunger punctured the tip of cartridge.The cartridge made contact with patient's left eye.The event was observed while inserting lens into the eye.Procedure was completed successfully using backup lens of same model and same diopter.Patient had recovered.No further information available.

Manufacturer Narrative

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.There are no discrepancies found during the mrr (manufacturing record review).A search revealed that no additional complaint was received from this production order.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.

Manufacturer Narrative

Device was returned for evaluation.As a result following fields have been updated; section d9: device available for evaluation: yes section d9: returned to manufacturer on: 6/22/2021 section h3: device evaluated by manufacturer: yes device evaluation: the 1mtec30 cartridge was returned inside iol folding carton box.Visual inspection using magnification was performed to the returned sample: residues of viscoelastic material were observed on cartridge.The cartridge tip was observed deformed and crack.The lens was also observed stuck at the cartridge tip section and the leading haptic was observed not folded.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 as stuck in cartridge and cartridge tip deformed/crack was verified.The complaint issue reported as override was not verified.Based on the analyzed of the returned, there is no indication of product quality deficiency.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.

• Brand Name: UNFOLDER PLATINUM 1 SERIES
• 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: 11741481
• MDR Text Key: 256592631
• Report Number: 2648035-2021-07699
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)210729(10)CH10987
• Combination Product (y/n): N
• PMA/PMN Number: K081545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2021
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CH10987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ZCU150 +19.0, SN (B)(6).
• Patient Age: 59 YR