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

Model Number DCB00V

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem Hyphema (1911)

Event Type  Injury  

Manufacturer Narrative

Age or date of birth, weight, and ethnicity: information unknown/not provided.Date of event: unknown, not provided.If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.Reporter phone number: (b)(6).Pma/510k: this report is being filed on an international device; tecnis optiblue simplicity preloaded 1-piece iol, model dcb00v that has a similar device, tecnis simplicity preloaded 1-piece iol model dcb00 which is distributed in the unites states under pma p980040.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that immediately after implantation of an intraocular lens (iol), a black membrane material adhered to the iol.The material could not be detached even by scrubbing and/or by being aspirated with irrigation/aspiration (i/a).The lens was cut with an iol cutter and removed.There was some iris bleeding when the iol was removed from the eye, but the operation was completed without any problems.The surgery time was extended 30 minutes; however, there was no health hazard issues after the lens was replaced.There was no patient injury reported.It was indicated that the injector was discarded.No further information was provided.

Manufacturer Narrative

Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: jul 27, 2021.Section d9: returned to manufacturer: yes.Device evaluation: the dcb00v device was not returned for evaluation as it was discarded.Only the intraocular lens (iol) returned inside folding carton box with direction for use (dfu), sheet labels and patient implant card.The lens was received cut in pieces and black membrane was observed on the lens.The reported issues were verified.Since the device was not returned for further evaluation, the complaint reported cannot be confirmed by the manufacturing site as related or originated during the manufacturing process.Product quality deficiency could not be determined.However, the lens was sent to an independent laboratory for further analysis.A visual examination performed revealed dark spots on various locations of a cut iol.The residue was tacky, but able to be removed with a needle-point tool.Based on the analysis dark spots appear to be a mixture, composed of protein and possibly a phosphate buffered saline solution (na, cl, p, ca, k) with an unknown sulfur species.Also, the unit was evaluated by the sme (subject matter expert).Sample of the cut lens was received with the black membrane observed in the corners of the lens.Visual inspection using magnification was performed.There is no sufficient evidence that suggest that the complaint sample was affected by the manufacturing process since the manufacturing process does not utilize any substance or processing aid containing mixture composed of protein and/or sulfur species.Manufacturing record review: the mrr (manufacturing record review) was performed and no discrepancies and/or deviations for similar issues were found during manufacturing record review.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.

• Brand Name: TECNIS SIMPLICITY
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 12222223
• MDR Text Key: 263438216
• Report Number: 2648035-2021-08187
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474636712
• UDI-Public: (01)05050474636712(17)240120
• Combination Product (y/n): N
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2024
• Device Model Number: DCB00V
• Device Catalogue Number: DCB00V0220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other